• Every day is different and you can enjoy supporting a range of roles.
• The role is generously compensated, and attracts a competitive base salary.
• Excellent career progression opportunities.

• Working with clients and hiring managers looking at current and future recruitment requirements
• Developing sourcing strategies to attract and promote top talent
• Leading interviews for key partners
• Partnering with hiring managers on complete recruiting life cycle
• Communicating with candidates to ensure efficiency and ongoing brand awareness
• Working with clients in identifying the right fit candidates
• Executing sourcing strategies for talent pipeline campaigns

• Relevant 3^rd level qualification
• 2+ years recruitment experience either in house or with a 3rd party agency
• Pharma industry related experience is preferred
• Brilliant communications skills
• Customer focused attitude
• Ability to engage with multiple customers
• Remote working experience
• Great relationship building skills

• Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
• The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
• Excellent career progression opportunities.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Serve as technical expert or lead projects/programs and technical staff to develop, test and implement significant new products, or operational improvements or devise new approaches to problems at the division/business unit.
• Conduct investigation activity/research and give technical advice to the adoption or integration of new technologies and their business impact.
• Lead in the development of standards and procedures and publish/communicate findings via IOI’s, presentations, white papers, etc.
• Review, validate & enhance design, conduct performance monitoring and capacity planning; install, test and upgrade releases and associated products.
• Partner with the functional groups within the IT organization to communicate and clarify business needs, contribute to development of long-range system plans, and ensure products and services are aligned with business needs.
• Provides strategic consultancy support to customers in defining or designing business processes and researching and identifying enabling technologies based on customer requirements.
• Actively seek ways to apply technology to business processes, researching and providing information on technical trends and competitors' practices relevant to the assigned client business.
• Ally with other IT functional areas to remain apprised of project status, and inform customer management of progress; conversely, keep the IT group's technology and service managers aware of user issues and potential potholes or resolve conflicts.
• Develop, motivate, and provide direction to technical team in a way that facilitates the creation of a team environment and enables team to fulfill the department's operation objectives.
• Accountable for total project scope, budget, completion within budget constraints and schedules completion date.
• Accountable for successful and timely completion of all tasks/projects under direct and matrix control.
• Post completion audit of project after implementation to verify expected benefits vs. costs, both development and operating.
• Project success is critical to the continued business success of the corporation.

• Four-year degree or equivalent experience in Process Control Engineering, Manufacturing Execution Systems (MES), Information Technology, Computer Science or Computer engineering. Equivalent experience is defined as six years combined experience in the above areas.
• 5-8 years of combined experience in Process Control System Integration (in addition to equivalent experience listed above, if applicable).
• Experience with MES/POMSnet, OSI-PI Historian (or equivalent data historian) or DeltaV and/or Foxboro Distributed Control System (DCS) (or equivalent DCS systems) preferred.

This is a shift based role, you will be required to work 12-hour shifts between days and nights on a monthly rotation.

As part of your new and exciting role you will assure the long-term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Act as key point of technical contact for aseptic fill finish activities.
• Supervision and execution of compounding, filling, lyophilization, equipment preparation, formulation, buffer preparation and support processing activities in the biologics fill finish facility to meet clearly stated operating objectives
• You will lead, coach & mentor your manufacturing team, across a 12-hour rotating shift, to maximize the effectiveness through clear and effective communication of task details and goals to their team members, to allow the biologics technicians to work effectively
• As part of this diverse and inclusive team, you will conduct on the floor promotion of a culture of contamination control and compliance with aseptic best practice.
• Communicate the departmental goals, to provide cost effective quality compliant products in a safe, effective manner
• We believe in collaboration so in this role, you will liaise with program management, supply chain, technical operations quality and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing
• Resolve operations/project issues by working with team members, project customers, and others as appropriate.
• Responsible for driving operations excellences and Key operations targets including OEE where applicable
• Provides direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits

What you need to apply:

• Minimum of 3 year’s experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry. 
• 3rd level qualification in a Science, Engineering or related scientific field, advanced degree is preferred
• Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
• Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing. 
• Has a technical background in pharmaceutical, biologics, or similar industries 
• A minimum of 1 year team direct supervisory experience in a team environment
• Flexibility with working 12-hour shift, rotating between days and nights on a monthly rotation
• Possess a strong technical knowledge and application of concepts, practices, and procedures.
• Works on problems of complex scope where analysis of situations or data involves multiple competing factors.
• Exercises judgment and advises management as to the appropriate actions

 Team Horizon is seeking a Visual Inspections Engineer for a Visual Inspections Engineer. This person will be responsible for supporting strategy to qualify samples /streamlining processes and taking part in threshold studies.

 Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 What you will be doing:

• To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.
• Develop and modify procedures as needed to support the manufacturing operation.
• Participate in process, equipment, and facilities validations efforts and projects implementations.
• Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.
• Execute protocols in a timely basis to meet the project schedule requirements.
• Participate and lead (as required) Process FMEAs for Visual Inspection
• Establish, Lead and Optimize the process for certification of technicians for visual inspection.
• Establish and maintain the defect library.
• Establish and execute the process for the trending of Visual Inspection Defects
•  Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements
• Provide Technical Input to guide the development of SOPs for Visual Inspection.
• Leadership of manufacturing and validation activities during project life cycle.
• Coordination with internal/external stakeholders for the evaluation of particles/defects
• Support of technical transfers for future product introductions to the site.
• Investigate process exceptions or malfunction incidents affecting the process.
• To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required.
• Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.
• May be required to support Cross functional teams and cost improvement projects.
•  Provide technical leadership to functional areas and collaborates with key stakeholders.
•  Leads the delivery of new training initiatives

 What you need to apply:

• A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
• At least three (3) years of total combined experience in Technical/Operations/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
• At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
• Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable. 
•  Experience in clean utilities is desirable.
• Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
• Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
• Understands and supports the principles of Perfect Performance.
•  Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
• Expected to handle all day-to-day training, learning & development queries, if major problem can refer to Team Manager.
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.

Why you should apply:

• This is an exciting opportunity to join a leading biopharmaceutical manufacturing company who work across several therapeutic areas.
• Excellent opportunity to leverage your organisation and project management experience by providing admin support to facilitate meetings, work with the SME to identify tasks and timelines, set up tasks and meeting follow ups, & identify critical path.

What you will be doing:

• Manages the development and implementation process of company's products and services involving cross-functional teams focused on the delivery of new products.
• Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
• Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Assures project quality by using standard development methodologies and by working with SQA to develop and execute project quality plans.
• Communicates project status by preparing standard status reports, and by leading and participating in departmental and customer project status update meetings.
• Resolves project issues by working with team members, project customers (internal and external), and others as appropriate.
• Consults with internal project groups by sharing project management knowledge and assisting other project team stakeholders in project management processes and techniques.
• Responsible to raise Change Plan: drive impact assessment, present CP to CFT meetings and drive approval up to Change review board
• Prepares, edits, files, assembles documentation such as reports or technical documents, records, or correspondence.
• Maintains numerical, alphabetical, chronological and/or subject filing system.
• Responsible for file maintenance and record keeping; locates and removes file material upon request.

What you need to apply:

• Degree plus 5 years of related work experience with a good understanding of specified functional area
• Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations. 
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.

As a QP for the site, you will work closely with our products throughout their manufacturing lifecycle, up until release from the site.

Why you should apply:

• This is an excellent opportunity to join a company who put their people & their patients first.
• You will have the resources and a global reach to empower your innovative mindset and make ground-breaking advancements happen.
• Make a lasting impact that's felt within healthcare and beyond.

What you will be doing:

• Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice and Annex 16 requirements.
• Certify that each batch is manufactured and checked according to relevant laws, GMPs, and product specifications
• Oversee the disposition of bulk products, determining release or rejection based on manufacturing and testing data.
• Assess and resolve day-to-day quality issues, ensuring products meet quality and safety standards.
• Support cross-functional teams in process improvement and cost efficiency initiatives.
• Provide technical leadership and collaborate with stakeholders to enhance product quality and process optimization.
• Make informed decisions within quality systems, adhering to regulatory standards, and handle quality queries from the operations team.
• Promote a culture of excellence in quality and compliance throughout the organization.
• Participate in internal and external audits, ensuring readiness and compliance with quality standards.

What you need to apply:

• Bachelor's degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry.
• MSc in Industrial Pharmaceutical Science or equivalent recognized for QP status under Directive 2001/83/EC, Article 49.
• Experience as a QP on a license preferrable
• Experience in aseptic processing and quality functions.

Why you should apply:

• Join a fast paced and diverse team, in a company who are committed to  discovering, developing, & manufacturing innovative human therapeutics
• Flexibility around remote working when the role allows

What you will be doing:

• In this role, you will be responsible for delivering on the qualification and validation program which will include planning and execution of validation/requalification activities on critical equipment.
• Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
• Develop, review, and approve validation plans, protocols, and discrepancy summary reports.
  Lead the execution of airflow visualization, filter integrity, velocity, and particle monitoring testing activities
• Lead the execution of cycle development, performance qualifications, and requalification programs for VPHP isolators.
• Collate and report relevant validation data and metrics.
• Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and standards.
• Provide validation support for quality management system, including change control, deviation, and CAPA processes.
• Coordinate projects and prioritize workload in line with site priorities.
• Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control
• Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
• Attend and contribute to staff meetings and training sessions as required.
• Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.
• Perform all tasks with due care and attention in accordance with Good Manufacturing Practices and  requirements, policies, and procedures.

What you need to apply:

• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem-solving ability and excellent oral and written communication skills
• 5+ years’ experience in a similar role. 
• Experience qualifying HVAC systems and/or executing VPHP qualifications.
• Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
• Independent, self-motivated, proactive, organized, able to multi-task in project environments, and skilled in communication and collaboration.
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Team Horizon is seeking a Validation Engineers for a leading pharmaceutical company in South Dublin.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Validation Engineer responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements.
• Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV’s), Functional Testing (FT’s), Site Acceptance Testing (SAT) and Performance Qualifications (PQ’s) associated with a Syringe Filling Line.
• Pre-Approve and Post-Approve validation protocols.
• Input into site Validation Master Plans and Standard Operating Procedures (SOP’s)
• Collate and Report on relevant validation data/metrics.
• Assist in exceptions and deviation resolution and root cause analysis.
• Reviews Validation planning documents detailing overall strategy for the project.
• Reviews and Approves Qualification summary reports (QSR)
• Generates Validation Summary reports.
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
• Any other duties as assigned.

What you need to apply:

• 6+ years experience in Engineering or Validation Technical qualification at third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Knowledge of safety and GMP requirements.
• Demonstrated strong Communication skills.
• Experience using Paperless Qualification Systems is preferred.
• Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry

Team Horizon is seeking a Senior MES Engineer for our client who are a global leader in the biopharmaceutical industry for their Mayo site.

The purpose of this role is to Maintain the MES (POMSnet) environment; to author and maintain recipes and worksheets and providing technical guidance and solutioning to the other MES Engineers. The MES Engineer will also Act as site escalation point for complex or challenging troubleshooting or recipe design. As well as providing project management guidance and expertise to the MES function.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic
• Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
• Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
• Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
• Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified.
• Liaise with the Global MES on the sites required system improvements.
• Provide support to other MES system users as required to ensure business continuity.
• Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
• Keep other recipe authors up to date on MES changes
• Documentation of all activities in line with cGMP requirements.
• Cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
• Adheres to and supports all EHS standards, procedures and policies. 

What you need to apply:

• Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
• A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.
• Be proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
• Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
• A good knowledge of IT systems is required for this role.
• SAP knowledge/experience in MM, PP and IM modules.
• Proven attention to detail and mental concentration, to always ensure total compliance with procedures.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Endotoxin testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug product samples
• Sterility testing
• Water sampling
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation,

Identifications and Autoclave.

• Writing technical reports
• Media fill reconciliation and inspection
• Weekend bioburden cover
• Perform analytical testing as a main priority with efficiency and accuracy
• Report, evaluate, archive, trend and approve analytical dat
• Troubleshoot, solve problems and communicate with stakeholders
• Initiate and/or implement changes in controlled documents
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope
• Write protocols and perform assay validation
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.?

What you need to apply:

• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab?
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products? 

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo.
• Reviewing & filing of QC calibration & maintenance documentation.
• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
• Conduct periodic reviews of instrument validation as part of validation life cycle.
• Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required
• Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
• Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
• Where applicable, owns and project manages change controls and adherence to Change Control metrics
• Supporting and managing the addition of project components to CMMA Maximo
• Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems
• Any other tasks/projects assigned as per manger’s request

What you need to apply:

• Bachelor’s degree in a Science related field is required.
• Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Lead and support NPI activities for product, processes and technology from early-stage development through to PPQ.
• Lead and manage cross functional teams across different skillsets and disciplines to perform activities required to deliver NPI's.
• Collaborate with cross functional teams including Process Development, Science & Technology (PDS&T), Quality, Manufacturing, Supply Chain and ECM to facilitate the smooth transition of new products from development to commercialization.
• Complete all site fit assessments for all the products from pipeline and ECM opportunities
• Provide technical direction and oversight and coordinate support for NPI activities across the entire biological manufacturing area
• Work closely with internal and external program management to ensure alignment on NPI schedules
• Ensure resource availability for all NPI related activities
• Build and maintain a mindset of innovation and continuous improvement withing the function.
• Provide leadership and mentoring for operations personnel during NPI activities
• Collaborate with external parties to ensure engagement and alignment and open communication throughout NPI activities
• Engage with external and internal partners to influence the design and implementation of robust process control strategies on process risk assessments
• Generate product transfer documentation to attest the completion of product transfer deliverables in advance of the application product transfer stage gate review
  provide technical input, review\ approval for documentation associated with NPI activities
• Ensure ongoing compliance with CGMP and EHS practices new
• Participate in NPI project gate reviews Interface with internal auditors and outside regulatory agencies\ auditors as the subject matter expert for new products and technology transfers

What you need to apply:

• Ph.D in Chemistry, Biochemistry, Chemical Engineering or related field Minimum 10 years experience in pharmaceutical or biotechnology industry
• Proven strategic leadership experience with the ability to inspire and motivate a diverse and global team.
• Extensive experience from working in an international organisation and across borders.
• Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development.
• CMC technical lifecycle management In-depth understanding of regulatory and quality requirements in relevant area

Why you should apply:

• Opportunity to be part a diverse team and an established company which offer career progression opportunities.
• They put their people first and live their diversity and inclusion values embracing all perspectives.
• Competitive salary & benefits package.

What you will be doing:

• Act as the global QA SME for qualification and oversight of GxP-relevant suppliers, including GMP, GLP, GCP, GDP etc., service providers.
• Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring.
• Conduct supplier audits (initial, routine, for-cause), prepare audit reports, track CAPAs, and verify implementation effectiveness.
• Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.
• Evaluate supplier quality systems and compliance with applicable international regulatory requirements (e.g., EMA, OECD GLP, VICH GCP, ISO/IEC 17025, HACCP, etc.).
• Provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance is considered in supplier selection.
• Support internal stakeholders (e.g., R&D, Manufacturing, QC, Regulatory Affairs, Procurement) in supplier-related investigations and risk assessments.
• Develop and deliver internal training on supplier qualification procedures and regulatory expectations.
• Represent QA in cross-functional teams involving outsourced activities, ensuring the integrity of GxP-related data and deliverables.
• Maintain accurate and current records in eQMS systems and supplier management databases.

What you need to apply:

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.
• Minimum of 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry.
• At least 5 years of hands-on experience in GxP supplier qualification and auditing, with demonstrated expertise in GMP and at least one of the following: GLP, GCP, GDP.
• Experience with laboratory testing, contract manufacturing, and/or clinical service providers preferred.
• Proficiency in English (written and oral); additional languages are an asset.
• Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.
• Proven ability to plan, conduct, and report external audits independently.
• Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification.
• Experience with quality investigations, CAPA management, and change control.
• Proficiency with QMS tools, audit tracking systems, and MS Office; experience with eQMS platforms preferred.
• Critical thinking, strong attention to detail, and ability to interpret complex regulations into operational requirements.
• Excellent communication and interpersonal skills; capable of engaging with diverse stakeholders globally.
• Willingness to travel domestically and internationally up to 25%

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

•  Develop as a drug product technical expert, to provide leadership and solutions troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices for parenteral products through the new product introduction (NPI) or commercial phases.
• Work with contract manufacturing partner SME’s, Global Operations, Contract Manufacturing Quality and drug product process teams.
• Work as a member of cross site teams to support contract manufacturers and to identify and resolve potential issues
• Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterisation, technology transfer, and process validation.
• Troubleshoot issues with drug product processing technologies and equipment.
• Identify and implement operational improvements for current and new sterile operations.
• Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to observe production operations and build relationships

What you need to apply:

• 3 -5 years' pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment
• Masters or PhD in a Science or Engineering or related discipline
• Experience with aseptic drug product processes such as; component preparation (siliconization, autoclaving, depyrogenation), sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection
• Experience with different aseptic drug product presentations such as pre-filled syringes, cartridges, lyophilised vials and liquid vials
• Experience with the quality testing methods and interpretation of results for biological molecules
• Aseptic drug product validation experience such as; media fill, sterilisation validation, equipment qualification, process validation
• Experience dealing with contract manufacturing organisations

This hands-on, lab-based position involves maintaining laboratory safety standards, preparing microbial cultures and reagents, performing microbiological tests, and supporting non-scientific staff in handling live organisms.

The scientist is also responsible for operating and maintaining lab equipment, managing inventory and supplies, conducting routine safety checks, and maintaining detailed records to uphold GLP and biosafety protocols. Collaboration with EHS, Facilities, and cross-functional teams is essential to ensure consistent adherence to health, safety, and quality standards.

Why you should apply:

• Join inspiring leaders and passionate colleagues committed to creating an inclusive, growth-focused, and rewarding workplace culture.
• Enjoy outstanding career development and progression opportunities.
• Highly competitive salary along with an excellent benefits package.

What you will be doing:

• Supporting the safe and efficient operation of BD’s microbiology laboratory and ensuring adherence to all requisite health, safety, and quality standards at all times during the operation of these laboratories.
• To write, maintain and enforce procedures relating to all areas of the microbiology laboratory and its related testing equipment.
• To assist in training a team of non-scientific staff and facilitate arrangements to introduce professional visitors to the laboratory.
• To operate and maintain laboratory equipment and perform microbiological testing to aid the non-scientific/ software associates
• To support and contribute to effective execution of audit activities.
• To assist in identifying and implementing operational procedures up to “best practice” standard in order to optimise use of resources.
• To co-operate with the relevant staff in developing and leading the introduction of new ideas and technologies
• Maintain inventory logs, monitor and restock lab supplies
• Ensure adherence to all codes of and guidelines relating to professional practice and including the maintenance of Quality Assurance standards.
• Conduct routine safety checks and walkthroughs to adhere to biosafety regulations.

What you need to apply:

• Be registered on the Medical Scientists Register - Maintened by the Medical Scientists Registration Board at CORU 
• Possess the fellowship or be eligible for fellowship of the Academy of Medical Laboratory Science (FAMLS) or equivalent. 
• Posses membership or be eligible for membershipof the Academy of Medical Laboratory Science (MAMLS) or equivalent.
• Experience in a Hospital Laboratory Microbiology Setting  2+ years of Satisfactory post-qualification experience. 
• Excellent communication skills including the ability to present information in a clear and concise manner  Demonstrate effective team and interpersonal skills 
• Excellent planning and organising skills  Demonstrate up-to-date knowledge of best practice in delivering a quality laboratory service and awareness of the requirements of ISO 15189 
• Demonstrate up-to-date knowledge of antimicrobial susceptibility testing and guidelines 
• Be familiar with laboratory information systems

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Arrange agreement among the project team, customers, and management on the goals of the project
• Develops and maintains the Project schedule/plan that addresses quality, objective, scope, cost, schedule, resources, and responsibilities - to deliver the project, and measure progress against schedule and budget
• Effectively communicate with everyone involved in the project
• Have a controlled scope in place, that is understood by all stakeholders and maintained throughout completion of the project
• Execute prudent risk and issue management.
• Maintains Actions/Risk and Decision logs
• Generates and owns the GMP change control.
• Motivate, support and direct project team members to deliver on project plan.
• Leads Team meetings and cross functional collaboration
• Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time

What you need to apply:

• Technical Degree and/or Masters’ or equivalent
• 5-8 years of experience (including min of 3yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment
• Preferred Experience: Portfolio Management, Portfolio Resource Management, Business Case Development  
• Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio,
• Trackwise Change Control & Document Management Systems

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Manage a lab team performing QC testing, ensuring compliance with data integrity policies and regulatory requirements.
• Conduct and supervise all aspects of API and OSD analytical testing.
• Ensure timely sampling, inspection, and testing, coordinating with teams for schedules and priorities.
• Participate in internal and external audits and address audit findings.
• Prepare technical reports, lead investigations, and implement CAPAs.
• Provide training and support to lab team to achieve daily and long-term goals.
• Present technical data to stakeholders to facilitate prompt decision-making.
• Report to the Senior QC Manager.

What you need to apply:

• M.Sc./B.Sc. in Chemistry or a related discipline.
• Minimum 4 years of experience in people management within a pharmaceutical lab setting.
• Strong knowledge of QA/QC operations, analytical testing for API and OSD.
• Excellent presentation and technical report writing skills.
• Strong communication and interpersonal skills, with a commitment to quality and compliance.

Why you should apply:

• Work on high-impact projects, grow your career, and be part of a global team dedicated to quality, safety, and innovation.

What you will be doing:

• Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
• Generation/maintenance/execution of the Site Validation Master Plan.
• Generation/maintenance/execution of Project Validation Plans and schedules.
• Generation of validation protocols and final reports to cGMP standards.
• Generation of validation investigations and implementation of corrective actions
• Creation/Review/Approval of various quality documents and test data.
• Management of validation, exception event, and change control processes.
  Maintenance and tracking of validation equipment, if applicable.
• Completing all required training before executing a task.
• Documenting all activities in line with cGMP requirements.
• Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
• Performing cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
• Coordinating activities to maximize the effectiveness of all of the team members.
• Maintaining the overall cGMP compliance of the production areas.
• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

What you need to apply:

• Qualification and/or degree in engineering or scientific discipline.
• 3 years plus validation/Quality experience.
• 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry.

Team Horizon is seeking a Automation Engineer (NPI) for a client in Mayo to provide technical support and program management to all manufacturing operations and NPI’s.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Provide technical support to all control system related issues. Tasks include, daily trouble shooting, optimisation, and documentation control.
• Leadership of control system qualification activities during project start-up.
• Life cycle management of the onsite control systems, to GAMP-5 requirements.
• Project management of control system elements of continuous improvement projects. Work closely with process engineers/ technical support chemists and other departments to deliver these continuous improvement projects.
• Project management and technical development of future integrations of the control systems, with planned MES and ERP systems.
• Adheres to and supports all EHS & E standards, procedures and policies.
• Define proposals for long term plans for control system maintenance and improvements for management.
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities

 What you need to apply:

• B.Sc or B. Eng Degree or Post Graduate Diploma in a relevant technical discipline.(Masters desirable) Technical/Business Knowledge
•  • 3+ years experience in process automation, with relevant experience of Vendor Packaged Equipment in a GMP environment in the pharmaceutical industry.
• 3 years experience of the 21 CFR Part 11 and EU Annex 11 requirements for automated systems in the pharmaceutical industry.
• 3 years plus experience of plant start-ups and/or new product introductions to GMP facilities. Must be able to lead these activities in a start-up environment.
• Strong knowledge and experience of configuring and troubleshooting complex equipment control systems including PLC systems, and SCADA/HMI applications.
• Knowledge and experience control system networks, e.g. Profinet, Profibus, Modbus or CANBus.
• Knowledge and experience of Ethernet based networks, and network architecture models.
• Knowledge and experience of interfacing systems with plant historians such as Ignition & OSI-PI using OPC interfaces.
• Knowledge and experience of the life cycle management of control systems, including backup, recovery, user access controls, configuration management and change management.
• Knowledge and experience of Windows operating system administration.

Why you should apply:

• This role offers the chance to lead a talented QA team within a highly regulated, dynamic, and collaborative environment, while playing a key role in ensuring that all products meet the highest standards of GMP, regulatory, and  quality requirements.
• A great opportunity for someone who thrives in a leadership role, enjoys influencing quality strategy, and is passionate about driving continuous improvemenT

What you will be doing:

• Ensure products manufactured meet requirements of end users, Regulatory Authorities, and company standards.
• Lead and manage the Quality Assurance team, providing guidance and support on quality and compliance matters.
• Act as a site contact for regulatory and customer audits/inspections (FDA, HPRA, etc.) and prepare site teams for successful outcomes.
• Manage CAPA (Corrective and Preventive Action) implementation, and follow-up activities.
• Collaborate cross-functionally to resolve quality issues, improve processes, and ensure continuous compliance with cGMP and other relevant regulations.
• Promote department goals by attracting, developing, and retaining capable QA staff.
• Contribute to talent management and professional development of QA personnel.
  Develop, review, and approve QA documentation as related to general QA activities.
• Provide oversight of batch record review, deviation investigations, change controls, and product release decisions.
• Support quality meetings and key quality metrics and trends.
• Communicate effectively with internal and external stakeholders, including the Quality and Compliance Group and regulatory bodies.
• Serve as a designee for the Quality Director as required

What you need to apply:

• Bachelor's degree in science, Quality, Engineering, or related field (
• Minimum of 8 years’ experience in the healthcare, pharmaceutical, or biopharmaceutical industry 
• At least 3 years’ supervisory/people management experience 
• Demonstrated experience with audits and/or inspections (FDA, HPRA, etc.) 
• High level of expertise in day-to-day quality and compliance decision-making In-depth knowledge of GMP requirements and regulatory frameworks 
• Strong attention to detail and commitment to compliance and quality standards 
• Ability to facilitate quality decision-making while maintaining a strong patient focus and upholding company reputation

Team Horizon is seeking an Automation Engineer for a client in the pharmaceutical industry who has proven expertise in Ignition SCADA and hands-on experience using Ignition SCADA across multiple pharmaceutical projects.

The successful candidate will play a key role in deploying, configuring, and supporting Ignition SCADA systems across various global manufacturing sites, while working collaboratively to improve operational efficiency and compliance.

 Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives
• Fully remote role with occasional travel to sites in Ireland.

 What you will be doing:

• Lead and support the deployment of Ignition SCADA solutions across multiple sites within the organization.
• Maintain, standardize, and optimize global use case templates for consistent SCADA deployment.
• Roll out global templates, ensuring uniformity and best practices across all deployments.
• Collaborate closely with IT and engineering teams to develop interfaces between Ignition and various enterprise-level systems (ERP/MES/LIMS/etc.).
• Develop, update, and enforce engineering standards and procedures related to automation and SCADA implementations.
• Troubleshoot, maintain, and optimize Ignition SCADA systems for maximum uptime and performance.
• Train and support local engineering/operations personnel on Ignition system best practices.

 What you need to apply:

• Bachelor’s degree in Engineering, Computer Science, or a related field.
• 3-5 years experience working on pharmaceutical automation projects, with expert hands-on knowledge of Ignition SCADA.
• Understanding of regulatory requirements (GMP, FDA, etc.) within the pharmaceutical industry.
• Proven track record of deploying SCADA solutions globally and maintaining standard templates or design assets.
• Experience delivering interfaces between SCADA and enterprise platforms (such as ERP, MES, SQL databases).
• Strong communication and collaboration skills to work effectively with cross-functional teams.
• Knowledge of engineering documentation standards and ability to author procedures.

Team Horizon is seeking a Sr Project Manager (Senior) for our client based in Dublin (Hybrid). The Senior Project Manager — Manufacturing Support is responsible for a broad variety of project management activities that support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations.

The role will help plan, coordinate and deliver New Product Introductions (NPIs), deviation lifecycle development, operational and strategic projects (including capital, reliability and process-improvement / volume initiatives). Embedded in Manufacturing Support, the post will partner closely with Direct Manufacturing, Process & Aseptic Owners, Quality, Engineering, Validation, MES/, Technical Writing and other site and global stakeholders to establish safe, compliant and sustainable project management that maintain supply continuity.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations.
• Project manage timelines associated with complex investigations (deviations, aseptic excursions, batch issues, equipment failures) owning timelines, meeting scheduling, communications and lifecycle visualisations / tracking.
• Maintain daily/weekly project momentum with clear project controls, ensuring on-site presence and hands-on leadership of cross-functional teams.
• Lead and facilitate project meetings and governance forums to accurately capture and nd track actions, timelines, deliverables, milestones and decision-points; clarify and document roles and responsibilities and ensure timely closure and verification of action owners’ commitments.
• Provide timely escalation of project risks and issues and make decisions that enable progress within the contract timeline.
• Effectively communicate with everyone involved in the project
• Have a controlled scope in place, that is understood by all stakeholders maintained throughout completion of the project
• Maintains Actions/Risk and Decision logs
• Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on timeScope of role
• Define and align project objectives with Direct Manufacturing customers and site leadership. Create and maintain comprehensive project plans that address quality, scope, cost, schedule, resources and manufacturing readiness.
• Project Manage medium to large technical projects (capital, reliability, NPI, lifecycle) from concept through design reviews, build, validation readiness and handover to operations.
   

What you need to apply:

• Technical Degree and/or Masters’ or equivalent 
• 5-8 years of experience (including min of 3yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment 
• Portfolio Management, Portfolio Resource Management, Business Case Development    
• PMP or PRINCE2 certification. 
• Experience with Lean Six Sigma methodologies. 
• Knowledge of industry-specific regulations and standards.    
• Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio, 
• Trackwise Change Control & Document Management Systems

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing site in Mayo

What you will be doing:

• Manage, lead and motivate a multi-skilled Operations group in an empowered team-based environment, ensuring full engagement of team members.
• Ensure daily operations are carried out in compliance with all appropriate safety, quality and environmental standards.
• Execute daily and weekly production plans to meet all Business Plan commitments.
• Ensure timely completion of all corrective and preventive actions to avoid repeats of Service and Quality defects, and all audit non-conformances.
• Ensure a consistently high level of communication with the Operations team members through daily, weekly, and monthly routines.
• Drive, manage and embed operational excellence and a continuous improvement culture within the team to deliver improvements through lean principles and systems.

What you need to apply:

• Third level qualification, diploma or degree in a business or technical discipline required.
• A minimum of 5 years’ experience in a high-volume manufacturing environment.
• Demonstrated experience in people management in a people focused, team-based environment.
• Excellent analytical, problem solving and decision-making skills.
• Excellent communication and interpersonal skills.
• Comfortable working in a team based, matrixed, ambiguous environment.
• Ability to manage multiple conflicting demands and to prioritize accordingly.
• High level of PC literacy. 

Why you should apply:

• Learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. 

What you will be doing:

• Develop, enhance and maintain strategies and plans to improve the overall quality of software, including test coverage and system performance.
• Provides strategic and tactical support of the Quality Engineering Function, based on an understanding of 21 CFR Part 820 and ISO Requirements.
• Owns and facilitates the Design Review and Functional Review Process for software products.
• Collaborates with Manufacturing and R&D to support software products, driving design improvements and monitoring measurable enhancements. Routinely interacts with multifunctional groups.
• Ensures  PI Systems divisional, departmental policies, procedures, practices, and facilities are in compliance with all applicable regulatory guidelines.
• Represent the Quality Function for New Product Development Core Teams and/or Technology Transfer Core Team
• Plays a key role as a core team member in software development projects, handling various tasks such as requirements, SW development planning, risk management, V&V, and other work.
• Remediates software-related audit findings and CAPAs.

What you need to apply:

• Bachelor’s degree in Electrical, Mechanical, Software or Biomedical Engineering or other relevant technical area with 6 to 7 years of experience, where 4 of those years are progressive experience in software development or lifecycle management.
• Or MS/MBA with 7 years of experience, where 5 of those years are progressive experience in software development or lifecycle management. 
• Ability and skill to effectively manage multiple tasks and lead execution of change management plans
• Ability and skill to handle the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, Six Sigma root cause analysis tools and project management techniques 
• Ability to effectively write communications that ensure clarity, accuracy and consideration of the audience 
• Ability to speak with clarity and express points of view in a variety of settings: one-on-one interactions, group meetings, and formal presentations 
• Ability to listen to others, including associates, managers, peers and customers, when making decisions and solving problems 
• Ability and skill to analyse using systematic analysis tools that include root cause, failure analysis and risk assessment to gather critical information and diagnose 
• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution 
• Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO).

Why you should apply:

• This is a high-impact role with autonomy and visibility across multiple functions.

What you will be doing:

• Ensure all Computerized systems are qualified in compliance with Data Integrity policies
  and regulatory requirements.
• Co-ordination / direction and active participation in the validation of site equipment,
  facilities, utilities, processes and software in compliance with company policies, FDA,
  European cGMP and GAMP standards.
• Generation/maintenance of the Validation Master Plans.
• Generation/maintenance of Project Validation Plans.
• Generation of validation plans, protocols and final reports to cGMP standard.
• Understanding of Risk based equipment qualification, Equipment Risk Assessments, Critical Elements Test Plan development
• Review / approval of all protocols and final reports.
• Management of validation change control process.
• Adheres to and supports all EHS & E standards, procedures and policies

What you need to apply:

• A minimum of 5-10 years’ experience in a cGMP regulated environment.
• A good understanding of regulatory requirements.
• Must have hands on experience of execution of IQ/OQ/PQ for Facilities/ Utilities/ Equipment in Pharmaceuticals or Medical Devices or Diagnostics 
• Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
• Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
• Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
• Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
• Requires total commitment to quality and maintaining a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic at all times
• Strong communication skills both verbal and written are required for the execution of this role.

Why you should apply:

• Direct ownership of end-to-end CQV activities across high-impact capital and equipment lifecycle projects.
• Working within a dynamic, cross-functional team on complex, regulated systems also provides opportunity for excellent professional growth, visibility, and the chance to influence best-practice validation strategies in a critical manufacturing environment.

What you will be doing:

• Ensure the activities are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
• Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process from initial design through qualification to validation maintenance (eg. Periodic review)
• Coordinates the qualification activities and maintain Equipment and utility systems in a validated state
• Development or qualification approaches and equipment family strategies
• Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
• Development and approval of C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQ’s, PQ’s etc. for the Vial and Syringe filling, formulation, inspection and utility areas in line with GMP’s, regulatory requirements and corporate standards.
• Ensures Startup of equipment/utilities is completed in a safe and coordinated manner. Ensures the safe startup of equipment and utilities.
• Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
• Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance to all necessary regulations.
• Participate in regulatory inspections, regulatory filings and RTQ’s (response to questions).
• Update and maintain Standard Operating Procedures (SOP's) in accordance with site and corporate requirements.
• Take ownership for quality compliance in all activities you are responsible for, Ensuring approaches are aligned with current guidelines (ICH/ASTM)
• Ensure the site change control procedure is adhered to.

What you need to apply:

• 6+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management
• Technical qualification at third level or equivalent in Engineering or science.
• Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects
• Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
• Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
• Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.
• Knowledge of safety, GMP and environmental regulatory requirements.
• Participate, when required, as a member of a multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team or NPI regulatory marketing applications.

Why you should apply:

• This role is an excellent opportunity because it places you in a influential QA position where your expertise directly shapes the quality and compliance of aseptic drug products that reach patients worldwide.
• You’ll act as a key quality decision-maker for new product introductions, tech transfers, and process validation giving you real ownership, visibility, and impact across the, site.
•  

What you will be doing:

• This role will ensure quality and compliance across integrated line qualification, media fill execution, and product introduction activities, working closely with Engineering, Operations, and Process Development teams.
• Operational Readiness, Validation & Documentation
  •          Provide QA leadership duringdesign of new rooms, development of materials/people/waste flows and contamination controls (gowning, cleaning, desinfection)ensuring operational robustness. QA review/approve associated risk assestments and SOP.
  •          Review and approve validation documentation including integrated line PQs, media fills, and environmental monitoring qualifications.
  •          Support QA review of MBR and recipe creation for filling, lyophilisation, and associated aseptic operations.
  •          Ensure readiness of operational documentation including SOPs, batch records, and contamination control strategies.
  •          Contribute to the review of contamination control, isolator qualification (including smoke studies and VHP qualification), and environmental monitoring performance qualification (EMPQ).
  •          Maintain oversight of validation and readiness documentation to ensure it is audit-ready, scientifically sound, and compliant with standards and cGMP.
• Technology Transfer & New Product Introduction (NPI)
  •          Serve as the QA Lead for technology transfer and NPI activities, providing quality oversight throughout process validation and product lifecycle introduction.
  •          Review and approve technology transfer documentation including process descriptions, PPQ protocols, validation reports, and risk assessments.
  •          Partner cross-functionally with Technical, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements.
  •          Ensure alignment of transfer activities with global validation and quality system standards.
• Quality Systems, Risk Management & Compliance
  •          Lead and support deviation, CAPA, and change control management related to operational readiness, validation, and tech transfer activities.
  •          Conduct quality risk assessments for new processes, interventions, and aseptic operations.
  •          Ensure data integrity and right-first-time execution across all readiness and validation deliverables.
  •          Support inspection readiness and regulatory audits, representing QA for validation and NPI areas

What you need to apply:

• Bachelor’s or Master’s degree in Science, Engineering, Biotechnology, or related discipline.
• Minimum 8 years’ experience in pharmaceutical or biotechnology manufacturing 
• Proven expertise in facility startup and Quality Oversight of Operational Readiness and technology transfer activities.
• In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections including EU/FDA GMP, Annex 1, and process validation lifecycle requirements.       Experience working in aseptic operations, relating to vial and syringe filling.
• Experience managing change control, deviations, and CAPAs through electronic QMS systems (e.g., TrackWise, Veeva Vault, PAS-X, SAP).

The Client provides a range of professional, technical, project management, property, fire & safety, and related services in respect of the procurement, development, operation, and maintenance of buildings, plant, and equipment. These services include design, specification, project management, supervision, and procurement associated with building and refurbishment works in the Cork /Kerry region.

Why you should apply:

• They put their people first and live their diversity and inclusion values embracing all perspectives.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

What you will be doing:

• The Fire Prevention Officer will be responsible, in respect of such premises and locations as may, from time to time be assigned to them for the following.
• Advise on the suitability of equipment to reduce risks within the organisation, trying where possible to standardise products in consultation with the organisation Procurement Team.
• Report as required to managers and relevant committees on areas of fire and infrastructural risk where action is required.
• Receive copies of accident reports relevant to their area of expertise, and action/investigate, if necessary. Providing accident investigation reports for accidents investigated
• Be a member of the organisation’s Integrated Quality and Risk committee, and where necessary be co-opted onto other groups as necessary.
• Monitor and report on the health and safety performance of external contractors engaged on Construction related activity on the organisation’s premises.
• Assist in the setting up and amendment of Emergency Plans.
• Provide an input into planning the expenditure in relation to Fire Safety by highlighting and prioritising essential works required.
• Regular inspections of buildings, means of escape and all fire-fighting equipment and ensuring that all such equipment is properly located, well-marked, in good repair and in good working order.
• Reviewing and, as necessary, drawing up of fire orders, including evacuation schemes for the various types of building and institution, including schemes for evacuation of all persons with particular regard to mentally ill and non-ambulant patients and to draw up fire plans of all the organisations buildings and premises in his / her area of responsibility.
• Regular and routine inspection of places, premises and equipment, which present a special risk of fire and reporting any breaches of the fire prevention code.
• Instruction of staff in each premises in: Avoidance of fire hazards, Summoning of the fire brigade, Operation of the fire alarm and fire equipment, and means of escape.
• Curtailment of an outbreak of fire, pending the arrival of the fire brigade, prevention of smoke spread and evacuation of danger areas.
• Arranging regular fire drills in each location and ensuring that they are properly carried out.
• Monitoring, by having regular tests carried out, the water supply in all divisions of each institution, to ensure that it is of sufficient volume and pressure for firefighting purposes and reporting any deficiencies in this regard. 
• Ensuring that all hydrants are clearly identified.
• Advising as appropriate regarding interpretation of Fire Protection Standards and Building Regulations issued by the Government Departments and ensuring their implementation.
• Monitoring all means of escape to ensure that they are always both safe and adequate and, kept operative and clearly indicated.
• Keeping proper records of all inspections, fires, evacuation drills, fire-fighting equipment and such other matters relating to his/her office as Fire Prevention Officer.
• Reporting in writing, to the Engineering Manager, at three-monthly intervals on the state of the fire prevention services in the organisation buildings and premises assigned to him/her.  Also, report immediately all outbreaks of fire, breach of the fire prevention order and failure to perform fire drill at the Organisations buildings and premises.  If so directed, the Fire Safety Officer will make out an annual report on all aspects of fire and safety pertaining to the organisation’s property in their area of responsibility.
• Arrange to have the fire prevention work programmes implemented under the direction of the Engineering Manager.
• Monitor and report on the management of Health Safety and Infrastructural Risk issues of the organisation.
• Assess the continuous professional training requirements for staff in the area and advise the Engineering Manager of the appropriate training courses and coordinating with the training providers on the course provided.
• Engage in the organisation’s performance achievement process in conjunction with your Line Manager and staff as appropriate.
• Monitor the performance and implementation of the organisations Safety Management programme by regular spot checks, by analysis of safety audit reports and accident and incident returns.
• Act as an information source and resource to management and staff on fire safety, general safety, health and welfare matters.
• Advise, guide and participate in the risk assessment process/inspection within the area of fire maintenance and infrastructural risk.
• Assist in the development of health and safety training programmes for maintenance staff which are to be harmonised throughout the company.
• Adequately identifies, assesses, manages and monitors risk within their area of responsibility.
• Support, promote and actively participate in sustainable energy, water and waste initiatives to create a more sustainable, low carbon and efficient health service.
• Achievement of targets and plans and completion of agreed programme within allocated budget.
• Act as spokesperson for the Organisation as required.
• Demonstrate pro-active commitment to all communications with internal and external stakeholders
• Develop good working relationships with other members of the team and with administrators of institutions in which maintenance staff are engaged

What you need to apply:

• Hold a HETAC level 7 qualification (NQF) in engineering, fire engineering, architecture, Health and Safety or Building Services/Building Survey. Or hold an equivalent qualification.
• Have two years’ experience in comparable Fire and Safety role.
• And Have a high degree of proficiency / expertise in Microsoft office.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Laboratory Supplier relationship management, including development and reporting of metrics and monitoring performance to continuously improve efficiency and effectiveness of suppliers.
• Building and maintaining strong partnerships with all external laboratory functions to increase overall effectiveness and success of programs.
• Ability to operate in highly matrixed teams.
• Project management of a portfolio of cross-disciplinary external projects traversing the areas of Drug Product, Drug Substance, and Attribute Sciences.
• Primary focus will be to manage delivery of analytical work packages (method qualification, method transfer, release testing, stability testing, characterization sample management ) with external contract laboratories
• Actively participate in cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from  Contract Testing Laboratory sites are consistently met, as well as lead issue resolution, problem solving and serve as an escalation agent.
• Responsible to ensure analytical escalations are captured and communicated accurately and timely
  - Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Ensure that designated lead programs meet compliance, speed, quality, and cost targets through strong scientific and technical understanding of the programs and drug product development.
• Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
• Supplier evaluation and selection
• This position will require occasional domestic and international travel

What you need to apply:

• Advanced degree in engineering or the sciences.
• Experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterization testing.
• Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
• Experience interfacing with domestic and international CTL /CRO organizations
• Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
• Demonstrated understanding of drug development and commercialization for synthetic and/or biologic therapeutics
• Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
• Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems
• Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management

The CQV Engineer collaborates closely with project teams, contributes to documentation, and actively participates in field execution. This role ensures systems are installed, commissioned, qualified, and validated in line with project requirements, regulatory guidelines, and industry standards.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing site in Mayo.

What you will be doing:

• Client-side lead to work with equipment vendors to support the CQV lifecycle activities as part of a new facility start-up project.
• Responsible for developing and executing commissioning and qualification documentation for new systems and equipment.
• This will include supporting the complete CQV lifecycle; Writing URS documents, review / approval of Design Specifications, input into the control strategy, development and execution of the test matrix (leveraged) to support offsite / onsite execution (as per ASTM E2500).
• Participate in and support field execution of commissioning and qualification testing, ensuring accurate data collection, evaluation, and reporting.
• Experience of working with equipment vendors to develop and execute the CQV lifecycle.
• Assist in troubleshooting, resolution of issues, and investigation of deviations during system start-up and qualification.
• Collaborate with engineering, construction, operations, and quality teams to ensure seamless project execution.
• Ensure adherence to cGMP, FDA, EU, ISPE, and other regulatory standards relevant to system validation.
• Assist with project scheduling, coordination of vendors/contractors, and inventory of required materials/parts for CQV activities.
• Maintain robust, compliant, and traceable documentation of all CQV processes.
• Identify opportunities for improvement and contribute to best-practice CQV procedures.

What you need to apply:

• Bachelor’s Degree in engineering or scientific discipline preferred.
• Direct experience performing validation studies in cGMP biopharmaceutical or aseptic filling environment is required.
• Knowledge of aseptic processing and liquid filling operations preferred.
• Must be able to analyse data using basic statistical methods.
• 3 years of CQV experience in a regulated industry (pharmaceutical, biotechnology, medical device, etc.), covering multiple systems: process, utilities, and/or HVAC.
• Demonstrated experience with development and execution of CQV protocols and documentation (FAT/SAT, IQ, OQ, PQ).
• Willingness to travel and participate in on-site fieldwork as required.
• Solid understanding of process equipment, clean utilities, black utilities, and HVAC system operations.
• Strong analytical, documentation, and organizational skills.

Why you should apply:

• This is an opportunity to lead high-impact, cross-functional supply chain projects that directly support the successful delivery of medical devices to patients
• You will work at a strategic level, partnering closely with senior leadership and global stakeholders to shape and implement critical supply chain initiatives
• The role offers exposure to end-to-end device supply operations, from supplier readiness and manufacturing through distribution and scale-up

What you will be doing:

• Understand the scope of work for each project as defined by the Director for Device Supply
• Develop project charters aligned with scope of project
• Establish resources required for successful execution of project
• Develop and manage project plans with clear objectives and milestone dates
• Engage with internal and external stakeholders for successful execution of projects
• Establish and maintain dashboards / scoreboards for each project to manage and communicate status
•  Apply lean methodologies in execution of projects and apply a lesson learned approach in the interest of continuous improvements
• Examples of projects to be managed include:
• Defining and implementing an appropriate SKU strategy
• Ensuring device specification requirements are met during manufacturing, storage, handling and transport
• Implement an injection molding tooling maintenance and replacement strategy
• Identify and implement improvements for volume scale up project
• Ensure suppliers meet receiving sites requirements
• Streamlined procurement, manufacture, supply and payment processes

What you need to apply:

• Bachelor’s Degree in a Science, Engineering or Supply Chain discipline
• Project management experience in pharmaceutical operations
• Experience in medical devices with specific understanding of MDR’s
• Knowledge and experience in application of continuous improvement, operational excellence methodologies such as lean six sigma

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• Excellent contracting rates on offer.

What you will be doing:

• To provide process expertise in one, or both of the following disciplines:
•  Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.
• Downstream to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation, bulk fill and storage.
• To author and review process transfer documentation, gap assessments, technical protocols and reports, clinical manufacturing documentation, process validation documentation, strategy documents etc...
• To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies.
• To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
• To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
• To identify and implement process improvements, e.g. yield, cycle time reduction
• To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
• May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
• To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution.Lead any key process changes using change control system.
• Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations.
• To author and review common technical document (CTD) sections and reports for regulatory agency submissions.
• To serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.

What you need to apply:

• Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization
• Technical and operational knowledge of multiple unit operations in cell culture and or downstream purification processing
• Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
• Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings
• Ability to present and defend technical and scientific approaches in both written and verbal form
• Ability to drive for results independently and adapt to rapidly changing priorities
• Experience of Technology Transfer activities is advantageous
• Experience of clinical manufacturing activities is advantageous
• Knowledge or experience of start-up or systems would be ideal
• Technical writing competency  
• B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
• M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
• Experience of authoring CMC sections of regulatory submissions

This role will be focused on electrical and mechanical design of Building Services including heating, lighting, controls systems, Heat pumps and Boilers systems. The role will be based in Ballina and will include site visits. Project will range from school projects, commercial fit outs and manufacturing projects.

Why you should apply:

• They put their people first and live their diversity and inclusion values embracing all perspectives.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

What you will be doing:

• Lead Design and specification of Electrical Engineering Solutions for Buildings to current regulations and design standards.
• Working directly with clients and project engineers to define project requirements and develop technical solutions.
• Lead Pre-Construction activities including, design development, construction details, services coordination, technical submittals, sub-contracts, etc.
• Provide technical support to the estimating, procurement, commercial, and project bid teams.
• Provide off site technical support to construction teams.
• Carrying out design and calculation work using relevant industry software (AutoCAD, Revit etc)

What you need to apply:

• Third Level Degree in Electrical, Mechanical or Building Services Engineering.
• 3+ years’ relevant experience, preferably building services systems.
• Strong technical skills in Electrical Engineering Services & Design.
• Familiarity with Irish building regulations
• Knowledge of Design Guides, Building Regulations, EN & IEC Standards.
• Experience with client, vendor, and contractor coordination. Proactive team player with excellent attention to detail.
• Proficiency in AutoCAD, Revit, or similar software

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Develop and implement site-wide master plans for process and cleaning validation activities.
• Lead the development, planning, and execution of validation strategies and PPQ protocols, including risk assessments, data evaluation, and technology transfer support.
• Oversee the review, approval, and maintenance of validation documentation, reports, and change control records.
• Partner cross-functionally with manufacturing, engineering, and quality teams to support continuous improvement initiatives.
• Ensure full compliance with global regulatory standards (e.g., FDA, EMA) and internal quality policies.
• Manage validation-related investigations, deviations, and the implementation of corrective and preventive actions (CAPAs).
• Deliver training to site personnel on validation processes, expectations, and best practices.
• Serve as the validation representative during internal audits, external audits, and regulatory inspections.
• Participate in risk assessments and design reviews across all business units.
• Track, analyze, and report weekly performance metrics (e.g., GTW, QMS, EHS, ComplianceWire).
• Support audit readiness activities, actively engage during audits, and contribute to audit responses and follow-up actions, including participation in internal and external audit programs.
• Manage revalidation schedules, regulatory response support, laboratory validation document reviews, and APR reporting in collaboration with business unit owners.
• Coach, develop, and upskill direct reports to ensure strong technical capability and leadership support at the site level.
• Lead, motivate, and communicate effectively with team members and management to drive engagement and performance.
• Conduct performance evaluations in line with company policies, including individual development planning.
• Maintain appropriate staffing levels aligned with business needs, including recruitment and selection.
• Develop and manage departmental budgets to achieve organizational objectives.
• Address underperforming KPIs by implementing robust and sustainable preventive action plans.

What you need to apply:

• Minimum of 9+ years of experience with a Bachelor’s degree, 7+ years with a Master’s degree, or 5+ years with a PhD in a scientific or engineering discipline (e.g., Chemistry, Microbiology, Pharmacy, Chemical Engineering, or a related field). 
• At least 7+ years of hands-on experience in pharmaceutical validation, including process and/or cleaning validation. 
• Strong working knowledge of validation-related regulatory requirements and guidelines (cGMP, FDA, EMA, ICH Q7, Q8, Q9, Q10). 
• Demonstrated strengths in project management, problem-solving, and organizational skills. 
• Proven ability to work effectively in cross-functional teams while managing multiple priorities and projects. 
• Excellent conflict resolution and stakeholder management skills. 
• Subject matter expertise in key validation areas such as cleaning validation, CSV, aseptic processing, process validation, and CPV. 
• Solid understanding of process validation, computer system validation, SCADA systems, continued process verification (CPV), sterilization, packaging systems, and associated technologies. 
• Strong awareness of current data integrity expectations is highly desirable. 
• Excellent written and verbal communication and presentation skills, with the ability to clearly and concisely present data to team members and senior management when required.

The Project Manager – New Syringe Fill Plant Engineering Readiness will report to the Associate Director. They will be responsible for managing projects within the Operations Readiness Programme for the new fill plant project. The successful candidate will have at least five to eight years of experience within the pharmaceutical or biotech industry and will have demonstrated project management skills.

Why you should apply:

What you will be doing:

•          Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions.

•          The ability to influence and lead cross functional teams to deliver their projects that ensure a smooth start up of the new vial filling line.

•          The ability to work independently and identify risks and mitigation pathways to ensure project delivery

•          A passion for continuous improvement applied to project management.

•          Lead and drive Engineering readiness for new filling plant.

•          Arrange agreement among the project team, customers, and management on the goals of the project.

•          Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up.

•          Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.

•          Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.

•          Works with workstream leads to develop and maintain the Project schedule/plan that aligns with the overall goals of the Programme.

•          Effectively communicate with everyone involved in the project

•          Have a controlled scope in place, that is understood by all stakeholders and maintained throughout completion of the project

•          Execute prudent risk and issue management.

•          Maintains Actions/Risk and Decision logs

•          Generates and owns the GMP change control.

•          Motivate, support and direct project team members to deliver on project plan.

•          Leads Team meetings and cross functional collaboration

•          Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time

•          Always ensure compliance to cGMP.

•          Ensure safety & compliance standards are maintained to the highest standards 

•          Ensure financial compliance in line with Business & Financial guidance 

•          Support a culture of personal responsibility within reporting structure 

•          High Energy and Commitment.

•          Ability to work independently.

•          Comfortable leading across multiple stakeholders & multinational teams.

•          Strong ability to influence and affect change.

•          Capable of resolving issues of conflict effectively.

•          A proven track record in the ability to transfer goals and objectives into measurable plans.

•          Ability to identify gaps/risks and put appropriate remediation plans in place.

•          Uses strong relationships to identify requirements and potential opportunities.

•          Employs project management techniques and Problem Solving.

•          Provides leadership, guidance, and advice in own field of project management

•          Knowledge or experience with MES and MBR projects.

•          Knowledge or experience with validation of Aseptic Filling Lines.

•          Any other duties as assigned.

What you need to apply:

•          Technical Degree and/or Masters’ or equivalent in Engineering 5-8 years of experience (including min of 2yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment.

•          Preferred Experience: Portfolio Management, Portfolio Resource Management, Business Case Development 

•          Systems / Equipment: MS Office, MS Project, MS PowerPoint and MS Visio, Change Control & Document Management Systems.

•          Preferred Requirements: Smartsheet.

Supporting the Capital Projects Team with site-based projects for Oral Solid Dose Manufacturing, Facilities and Packaging operations.

Why you should apply:

What you will be doing:

•          Supporting the Capital Projects Team with site-based projects for Oral Solid Dose Manufacturing, Facilities and Packaging operations.

•          Supporting and executing validation support activities on site.

•          Partaking or leading potential continuous improvement programs, process mapping and gap analysis.

•          Optimisation of existing processes to achieve desired targets.

•          Delivering projects and assigned duties on time and on budget.

•          Coordinating changes using the approved change control procedure to ensure that cGMP is adhered to.

•          Supporting validation activities for project activities, including the review of validation documentation and attendance of validation activities.

•          Designing and writing summaries for regulatory compliance or project specific documentation, including URS, DS and detailed project schedules using MS Office applications (Project, Word, Excel, Visio, etc.).

•          Updating project details on a regular basis, leading project teams during scheduled project meetings, providing feedback and updates to team and senior management.

•          Any other duties as assigned.

What you need to apply:

•          Bachelor’s degree in Engineering.

•          5 years' experience in the Pharmaceutical Industry as a Project Engineer.

•          Experience in cGMP, general packaging systems and serialisation is advantageous.

•          Ability and proven track record of working and managing multiple departmental teams for operational and capital projects.

•          Excellent technical writing ability.

•          Strong documentation skills.

•          Strong interpersonal and communication skills.

•          Must work to the highest engineering standards.

•          Have strong technical and problem-solving skills.

•          Willingness to travel within Europe (minimal travel depending on projects). Hybrid/flexible working.

 Team Horizon is seeking a MES Engineer for a client in Mayo. The purpose of this role is to maintain the MES environment; to author and maintain recipes & worksheets. As well as troubleshooting ad providing solutions for MES and SAP problems in recipe execution and recipe authoring.

 Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 What you will be doing:

• Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic
• Design, create, write and execute, test and validation protocols, risk assessments, and system documentation.
• Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
• Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
• Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-arounds and fixes identified.
• Liaise with the Global MES on the sites required system improvements.
• Provide support to other MES system users as required to ensure business continuity.
• Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
• Keep other recipe authors up to date on MES changes
• Documentation of all activities in line with cGMP requirements.
• Cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
• Adheres to and supports all EHS standards, procedures and policies. 

What you need to apply:

• Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
• A minimum of  2 years authoring experience preferably using POMSnet.
• Be familiar with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
• Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
• A good knowledge of IT systems is required for this role.

Team Horizon is seeking a Digital Transformation Project Manager for a client in Mayo. This role oversees a portfolio of digital transformation initiatives designed to enhance operational efficiency, optimize manufacturing processes, and drive a culture of innovation and excellence.

The ideal candidate brings a strong understanding of digital technologies, project management methodologies, and the biopharmaceutical industry, with the ability to translate strategy into impactful execution.

 Why you should apply:

• Contribute your passion and expertise in digital transformation to impact the future of manufacturing and set new standards for operational excellence. You will play a key role in my clients digital transformation journey.
• You’ll work in a dynamic, collaborative environment where your ideas are valued, your voice matters, and your expertise directly shapes the future of the organisation.
• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:

• Coordinate a portfolio of digital transformation projects, liaising with above-site teams and SMEs to represent the Westport site.
• Collaborate with leadership to develop and implement digital strategies supporting operational and business goals.
• Collaborate with cross-functional teams, including IT, operations, regulatory affairs, and quality assurance, to gather requirements and ensure alignment of project goals.
• Drive value analysis and business case development for both new and existing digitalization projects
• Communicate project status, risks, and milestones to stakeholders at various levels.
• Develop and implement change management strategies to ensure broad user acceptance and successful adoption of initiatives.
• Represent the Business/Site in the deployment of digital tools and technologies, including system architecture and configuration discussions, acting as the operations/business voice in technical forums.
• Lead cross-functional teams in project delivery, ensuring projects are completed on time, within scope, and with clear stakeholder engagement.
• Establish and monitor KPIs to measure the success and performance of digital transformation initiatives.
• Ensure all initiatives comply with relevant regulations and standards.

 What you need to apply:

• Bachelor’s degree in Business Administration, Information Technology, Engineering, or a related field.
• Proven experience in digital transformation and project management, preferably in a manufacturing or biopharmaceutical environment.
• Experience in Lean, Six Sigma, or other process improvement methodologies.
• Knowledge of or strong interest in digitalization, technology, and operational excellence principles (e.g., IoT, AI, robotics).
• Excellent project and portfolio management skills, with the ability to multitask and manage cross-functional resources.
• Strong communication, analytical, and problem-solving skills; demonstrated ability to influence stakeholders at all levels.

Preferred qualifications

• Master’s degree in a related area is advantageous.
• Certifications such as Lean Six Sigma Black Belt, PMP, or credentials related to Industry 4.0.
• Experience with Industry 4.0 technologies and leading digital manufacturing projects.

The Engineer will support DV planning, execution, and reporting. This Engineer will cover all documentation, project management, requirements review, test equipment bring up, testing and reporting across all environmental test activities.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing site in Galway

What you will be doing:

• Test service request process, review and analysis.
• Analyse customer specification with the product Project Team Member and quality PTM, challenge the tests requested and define the final validation plan to build the final offer.
  Define the need of specific tools or bench (characterization, reliability...)
• Define also the associated budget.
• Write the detailed validation plan and test specification including both customer validation and also company requirements (to achieve quality targets)
• Schedule the validation plan and manage the test with the support of laboratory resources (technicians…)
• Responsible for the main relationship with the customer and project team for environmental validations (methods and results) wherever the tests are located (Troy, Shenzen, Bietigheim, Prague, external lab…).
• Work in parallel with the project team; contribute to correct the design in order to meet product performance.
• Manage the configuration and logistics of tested parts
• Lead validation FMEA generation for assigned project
• General DR’s for software, hardware & product design reviews, problem resolution, FMEA analysis.
  3)
• Manage the planning inside the laboratory and allocated resources (technicians, tools, benches,…)
• Responsible to obtain the specific tools needed for the validation (need specification and follow-up).
• Manage the cost of the validation activities.
• Familiarise with working system using bench equipment to enable view on delivered product and to understand customer problems.
• Carry out all work to comply with Quality Management System and Validation Engineering Processes e.g. ASPICE, ISOTS16949.
• Work with Methods & Tools (M&T) team to develop test environment solutions to enable Design & Process Validation (DV/PV)
• Test setup and verification of test platforms.
• Test script development (using NI LabVIEW / TestStand)
• Execution of testing using lab equipment (using thermal chambers, IPx) as per test specification
• Safety focussed and dedicated to maintaining high quality standards
• Report validation status to the project team and management on a regular basis (QRQC, 5mm…)
• Generation of test reports, peer-reviews of data and follow up on approval
• Create daily and weekly activity report on project and non project related activities using dashboards made available
• Perform problem management role interfacing with customer, allocation of Device Under Test (DUT) failures to appropriate functions and leading weekly review
• Participate in lessons learned across the various projects

What you need to apply:

• A relevant Technical Engineering Degree e.g. Computer & Electronic Engineering, Physics & Instrumentation, Mechatronics.
• Min 3 years test engineering experience Proficient in National Instruments (LabVIEW/or TestStand) Computer literate in MS Office suite (ECDL)

The role will be responsible for the Syringe Inspection Equipment elements of the new facility, including implementation and ensuring operational readiness of the equipment.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• The role will be responsible for the Syringe Inspection Equipment elements of the new facility, including implementation and ensuring operational readiness of the equipment.
• As a member of the Site Engineering team, support the existing manufacturing facility, with a focus on syringe inspection equipment.
• Support the manufacturing readiness strategy, startup, and validation of new systems and equipment to ensure compliance with company standards and fit-for-purpose requirements.
• Assist with equipment deliverables, including setup, spare parts management, functional testing, start-up support, and sustaining equipment in operation.
• Collaborate with diverse groups including Manufacturing, Quality, PD, Automation, IS, EHSS, and Global Engineering to ensure successful project delivery.
• Establish maintenance strategies and develop initial preventive maintenance (PM) programs for process equipment.
• Any other duties as assigned.

What you need to apply:

• Bachelor’s degree in engineering with typically 5+ years of experience in engineering projects and systems.
• Fundamental knowledge of applicable quality management and regulatory requirements.
• Strong leadership, technical writing, and communication/presentation skills.
• Experience developing strategies for new technology deployment.
• Demonstrated ability to foster a culture of clear communication, collaboration, and engagement at all levels for effective decision-making.
• Manufacturing experience in a biopharmaceutical formulation/fill/finish facility.
• Strong technical ability to analyse and resolve complex problems.
• Experience in vendor management, with a focus on equipment suppliers.
• Independent, self-motivated, organized, and able to multi-task in project environments.

Support the Facilities Project Manager in the delivery of Facilities-related capital and operational projects.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Participate in the full project lifecycle, including concept development, scope definition, detailed design, execution, commissioning, and close-out, in accordance with the site Engineering Project Delivery process.
• Drive the safe execution of works in compliance with site procedures, corporate standards, and applicable regulatory requirements.
• Review project works for installation quality and complete system walkdowns, punch-list management, and system turnover activities.
• Provide technical and operational support for site Facilities systems, including but not limited to:
  HVAC System.
• Support the operation and maintenance of HVAC systems, including AHUs, chillers, HEPA filtration, isolator air handling, pressure cascades, and environmental control systems.
• Apply GMP and regulatory requirements related to temperature, humidity, differential pressure, and cleanroom classification.
• Interpret engineering documentation including P&IDs, ductwork schematics, and control logic.
• Support monitoring and alarm management through BMS / EMS systems, including calibration and data integrity requirements.
• Support the management of mechanical and electrical lift systems, including control panels, safety interlocks, and load requirements.
• Act as site SME for warehouse and vertical storage systems including maintenance, operation and lifecycle management.
• Ensure compliance with statutory and regulatory requirements (e.g. LOLER, EN81).
• Coordinate preventive maintenance activities and contractor oversight.
• Review inspection reports, safety certificates, and support resolution of identified non-conformances.
  Electromechanical Door Systems.
• Support electro-mechanical door systems, including sensors, control units, actuators, and safety features.
• Assist in troubleshooting issues such as misalignment, sensor faults, or cycle failures.
• Ensure systems support GMP material and personnel flows and site segregation requirements.
• Support vendor performance management, servicing activities, and documentation review.
• Develop, maintain, and continuously improve Facilities preventive maintenance plans.
• Utilise computerised maintenance management systems and applications (e.g. CMMS/Maximo) to plan and document technical activities and asset spares management.
• Support planning, scheduling, and execution of site shutdowns and outage activities.
• Contribute to system reliability, compliance, and inspection readiness
• Support cross-functional coordination with Engineering, Quality, EHS, and Operations as required.
• Bachelor’s degree in Engineering or a related technical discipline, or equivalent relevant experience.
• Minimum 3–5 years’ experience in a GMP-regulated manufacturing environment, preferably biopharmaceutical.
• Working knowledge of Facilities systems and infrastructure within a regulated manufacturing site.
• Equipment troubleshooting and maintenance strategies and systems.
• Strong organisational skills with the ability to manage multiple priorities.
• Effective written and verbal communication skills.

What you need to apply:

• Bachelor’s degree in Engineering or a related technical discipline, or equivalent relevant experience.
• Minimum 3–5 years’ experience in a GMP-regulated manufacturing environment, preferably biopharmaceutical.
• Working knowledge of Facilities systems and infrastructure within a regulated manufacturing site.
• Equipment troubleshooting and maintenance strategies and systems.
• Strong organisational skills with the ability to manage multiple priorities.
• Effective written and verbal communication skills.
• Experience supporting Facilities systems within the pharmaceutical or biotechnology industry.  Familiarity with GMP and Good Documentation Practices.
• Experience supporting capital project delivery in an operational manufacturing environment.
• Ability to build effective working relationships and partnerships at all levels of the organisation.
• Experience working with CMMS systems (e.g. Maximo/SAP).
• Strong problem-solving skills and a proactive, self-motivated approach.
• Demonstrated leadership potential and a flexible, team-oriented work ethic.
• Commitment to treating colleagues, contractors, and stakeholders with dignity and respect.

Team Horizon is seeking an Automation Engineer for a pharmaceutical client in Dublin who will support day to day operation of complex automation systems.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Safety: Support a safe working environment by complying with all pertinent environmental health/safety practice and regulations.
• Maintain: Be the System Owner for automation systems in a GMP-regulated manufacturing setting ensuring systems are maintained in the validated state.
• Investigate: Lead and support incident investigations and troubleshooting efforts related to manufacturing automation systems.
• Improve: Implement improvements related to corrective or preventative actions; including software changes, and updates to design documentation and standard operating procedures.
• Innovate: Analyse the design of current systems, to recommend continuous improvements in line with the latest technology and regulatory standards. Support new product or technology introductions by performing engineering assessments, implementing automation system changes, and supporting engineering runs.

What you need to apply:

• Bachelor’s degree in Automation Engineering, Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering with 5+ years’ experience in operations/manufacturing environment.
• Background in automation design, installation, programming. Experience with validation and lifecycle maintenance is an advantage.
• Experience in one of the following automation specialties is an advantage:
  • Building Management Systems (Siemens Desigo)
  • Clean Utilities generation and distribution (Rockwell or Siemens PLCs)
  • Biopharmaceutical Formulation and/or Fill/Finish (Rockwell or Siemens PLCs)
  • Inspection or Packaging facilities (Rockwell / B&R / Siemens PLCs)
  • Experience in programming and troubleshooting of PLC, HMI, SCADA, Serialisation and Vision Systems. The systems include:
    • PLCs: Siemens S7-300/400/1500, B&R, and Rockwell
    • HMIs: Siemens and Rockwell.
    • SCADA: iFix, InTouch, Zenon, PCS7, and Rockwell FTView. FT Batch.
    • Fieldbus: ControlNet, DeviceNet, Profibus, Profinet, AS-I, BACnet etc.
    •  Vision Systems: Cognex, Keyence
  • Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11.
  • Working knowledge of network architecture technologies including TCP/IP and Firewalls.
  • Independent, self-motivated, organised, and able to multi-task in a manufacturing environment
  • Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
  • Solid technical writing, and communication/presentation skills.
  • Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals.
  • Travel at various times may be required to support training and vendor visits.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

•  Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo
• Reviewing & filing of QC calibration & maintenance documentation.
• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
• Conduct periodic reviews of instrument validation as part of validation life cycle.
• Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
• Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
• Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
• Where applicable, owns and project manages change controls and adherence to Change Control metrics
• Supporting and managing the addition of project components to CMMA Maximo
• Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems
• Any other tasks/projects assigned as per manger’s request

What you need to apply:

• Bachelor’s degree in a Science related field is required.
• Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• Excellent contracting rates on offer.

What you will be doing:

• Perform all lab functions in compliance with cGMP
• Follow written procedures for the following tests, as trained and qualified: Gel electrophoresis (SDS-PAGE, IEF), ELISA and plate based assays (potency and residual assays such as HCP and ProA)
• Stability scheduling and testing.
• Recognize and report aberrant test results and sample conditions.
• Provide QC SME and day to day technical guidance to QC biochemistry analysts.
• Training of new analysts in specific assays.
• Drive continuous improvement initiatives within the QC department.
• Lead and complete execution of investigations/CAPAs in a timely manner.
• Provide lab support including reagent preparation, cleaning, and routine equipment maintenance.
• Ensure training is current for all job functions performed.
• Order, stock and receive laboratory supplies.
• Complete all required documentation legibly and accurately.

What you need to apply:

• BSc in Chemistry or a biological science, with 4-7 years’ experience, or equivalent combination of education and experience.
• A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
• Ability to follow written procedures with close attention to detail
• Ability to function with minimal supervision for routine job duties.

Why you should apply:

• Contribute your passion and expertise in digital transformation to impact the future of manufacturing and set new standards for operational excellence. You will play a key role in my clients digital transformation journey.
• You’ll work in a dynamic, collaborative environment where your ideas are valued, your voice matters, and your expertise directly shapes the future of the organisation.
• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:

• Acts as a site Subject Matter Expert for Aseptic Manufacturing.
• Provides key input for setting up the Manufacturing process.
• Provides key input for the Manufacturing Batch Record.
• Responsible for ensuring that Operations procedures required for Aseptic Manufacturing are in compliance with relevant Safety and Environmental Regulations, Aseptic and GMP Regulatory requirements and Network Aseptic Best Practice.
• Ensures appropriate use of Risk Management tools to drive Aseptic performance/ Sterility Assurance.  Responsible for completing pFMEA and What If/ HAZOP assessments.
• Partners with other members of the Site Aseptics Team (e.g. Quality SMEs, Engineering SMEs, Aseptic MQA and Aseptic mentors) to ensure required support is provided to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner, assuring sterility of the product. 
• Drives a high-performance culture in Aseptic Manufacturing, through communication and colleague engagement.  Drives a culture of Speak-Up.
• Routinely observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate, in particular during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, EM plate handling and Interventions.
• Actively leads and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.
• Owns analysis and trending of EM data (Facility and Personnel) including ownership of the EM Visualization tool and its standardized use across functions.  Develops and executes action plans to address EM trends.  Provides key input to EM procedures.
• As part of the Site Aseptics Team, drives continuous improvement of Aseptic Manufacturing procedures through:
  a) Continuously assessing, interpreting, and applying new Aseptic Manufacturing Regulations to Site operations in a timely manner.
  b) Development and implementation of Best Practices in Aseptic Manufacturing.
• Ensures that all procedures and changes follow Site Change Control procedures.
• Provides key input into the Site Contamination Control Strategy.
• Provides key input into site APS strategy.
• Provides key input into Site LRP related to Aseptic Manufacturing.
• Provides key input into Cleanroom/ Equipment/ Utility design, Qualification and Re-Qualification processes, Preventative Maintenance strategies and real-time monitoring.
• Supports regulatory audits as Aseptic/ Sterility Assurance subject matter expert
•  Supports training of Operations personnel in Aseptic technique and in Aseptic processing related procedures.
• Participate in routine leadership GEMBAs of Manufacturing and Testing areas.

What you need to apply:

• Third Level Degree in a Science, Quality or Engineering discipline.
• 5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing (non-negotiable)
• Strong knowledge of Regulatory Requirements including EU GMP Annex 1 'Manufacture of Sterile Medicinal Products,' FDA requirements including 21 CFR Part 610 (General Biological Products Standards), 21 CFR Part 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs) and 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and FDA guidance documents such as 'Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.'
• Author and subject matter expert for risk management tools that drive aseptic performance / sterility assurance including contamination control strategy, pFMEA, HAZOP, What if?
• Experience in tracking and trending environmental monitoring data as microbial subject matter expert. 
• Experience in investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.
• Excellent communication skills

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Develop and implement site-wide master plans for process and cleaning validation activities.
• Lead the development, planning, and execution of validation strategies and PPQ protocols, including risk assessments, data evaluation, and technology transfer support.
• Oversee the review, approval, and maintenance of validation documentation, reports, and change control records.
• Partner cross-functionally with manufacturing, engineering, and quality teams to support continuous improvement initiatives.
• Ensure full compliance with global regulatory standards (e.g., FDA, EMA) and internal quality policies.
• Manage validation-related investigations, deviations, and the implementation of corrective and preventive actions (CAPAs).
• Deliver training to site personnel on validation processes, expectations, and best practices.
• Serve as the validation representative during internal audits, external audits, and regulatory inspections.
• Participate in risk assessments and design reviews across all business units.
• Track, analyze, and report weekly performance metrics (e.g., GTW, QMS, EHS, ComplianceWire).
• Support audit readiness activities, actively engage during audits, and contribute to audit responses and follow-up actions, including participation in internal and external audit programs.
• Manage revalidation schedules, regulatory response support, laboratory validation document reviews, and APR reporting in collaboration with business unit owners.
• Coach, develop, and upskill direct reports to ensure strong technical capability and leadership support at the site level.
• Lead, motivate, and communicate effectively with team members and management to drive engagement and performance.
• Conduct performance evaluations in line with company policies, including individual development planning.
• Maintain appropriate staffing levels aligned with business needs, including recruitment and selection.
• Develop and manage departmental budgets to achieve organizational objectives.
• Address underperforming KPIs by implementing robust and sustainable preventive action plans.

What you need to apply:

• Minimum of 9+ years of experience with a Bachelor’s degree, 7+ years with a Master’s degree, or 5+ years with a PhD in a scientific or engineering discipline (e.g., Chemistry, Microbiology, Pharmacy, Chemical Engineering, or a related field). 
• At least 7+ years of hands-on experience in pharmaceutical validation, including process and/or cleaning validation. 
• Strong working knowledge of validation-related regulatory requirements and guidelines (cGMP, FDA, EMA, ICH Q7, Q8, Q9, Q10). 
• Demonstrated strengths in project management, problem-solving, and organizational skills. 
• Proven ability to work effectively in cross-functional teams while managing multiple priorities and projects. 
• Excellent conflict resolution and stakeholder management skills. 
• Subject matter expertise in key validation areas such as cleaning validation, CSV, aseptic processing, process validation, and CPV. 
• Solid understanding of process validation, computer system validation, SCADA systems, continued process verification (CPV), sterilization, packaging systems, and associated technologies. 
• Strong awareness of current data integrity expectations is highly desirable. 
• Excellent written and verbal communication and presentation skills, with the ability to clearly and concisely present data to team members and senior management when required.

Why you should apply:

• You’ll work in a dynamic, collaborative environment where your ideas are valued, your voice matters, and your expertise directly shapes the future of the organisation.
• If you’re driven, curious, and ready for the next step, this role is where you can thrive

What you will be doing:

• Recruitment will be focused on a specific team/function, or other areas as assigned.
• Responsible for attracting top talent and developing a strong, qualified candidate pool for current and future openings.
• Additional job duties include pre-screening candidates, project management, partnering with team members to develop sourcing strategies and providing talent for open positions.
• Demonstrate ability to proactively identify, source and manage talent pools aligned to business priorities.
• Core responsibility is to manage open job requisitions, update and manage SmartRecruiters, achieve recruiting metrics and report key accomplishments.
• Will also compile and communicate the knowledge base, industry overviews, and market trends, data and analytics to team members and business leaders.
• Will prepare and approve offer packages, providing equity & market competitiveness data research.
• Ensure compliance to state/federal employment laws and policies and practices for applicant tracking compliance and reporting metrics.
• Establish a true business partnership with hiring managers and leadership on all staffing related activities and issues.

What you need to apply:

• Bachelor's degree required.
• 2-3+ years recruitment experience in a competitive, fast-paced environment required.
• Must project a strong business presence and have the ability to instill confidence in clients and to deliver results.
• Proactive recruiting and sourcing experience required.
• Healthcare/Pharmaceutical industry recruitment experience strongly preferred.
• Experience in managing requisitions within SmartRecruiters preferred.

This position reports to the Operations Engineering Manager and is responsible for leading and managing a team comprising of engineers, technicians, and apprentices. The Engineering Manager support our API (Active Pharmaceutical Ingredients) business unit. 

Your role will involve team development, budget management, liaising with production and ensuring compliance with policies related to Personnel, Quality, Engineering, Safety and Finance.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• This is a varied position which requires cross-functional collaboration with contract maintenance providers, production, technical operations, quality and other personnel to ensure equipment performance is maximized. Your role will involve working on a variety of projects ranging from continuous improvement to new product introductions.
• Establish in conjunction with the Operations Engineering Manager the department goals, schedules and timetables for activities. 
• Assist with the management and support of manufacturing equipment development. 
• Support the API Engineering Team in ensuring that manufacturing equipment is maintained to meet the required legal, divisional and corporate standards. 
• Prepare appropriate CAPA plans and implement timelines. 
• Undertake specific investigations, and equipment monitoring, with a view to improve manufacturing performance e.g., reducing plant downtime and maximizing Plant output and yield.   
• Implementation of equipment/process upgrade in an environment of continuous improvement. 
• Develop monthly engineering metrics and provide management reports in a timely manner. 
• Ensure relevant budgets are within target and prepare capital expenditure requests for plant as required.
• Ensure successful external, Division and Corporate audits. 
• Ensure safety standards are met, and safe working practices are adhered to.  
• Manage internal and external plant projects as needed. 
• Supervise and manage relationships with external contractors. 
• Attend relevant meetings and drive actions to closure. 
• Any other duties as assigned.

What you need to apply:

• Degree (Level 7 or above) in engineering or scientific area (Chemistry)
• Minimum of 6 years pharmaceutical industry with a minimum of 2 years’ experience as an Engineering Supervisor.
• Previous experience in an active pharmaceutical manufacturing facility, particularly within the Engineering Department, is required.
• Experience with glass lined vessels, reactors, pumps, heat exchangers, ATEX, solvent handling. High level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures.
• Strong problem-solving skills with the ability to make prompt decisions on engineering related issues

This role will work closely with the Engineering Technical Authority (ETA), Site Engineering, Manufacturing, Quality, and external vendors to ensure projects are delivered safely, compliantly, on schedule, and within budget.
The Project Manager will coordinate a cross functional team and is responsible for, coordinating technical, operational, CQV and External Suppliers.

This role reports directly to the Engineering Technical Lead for the Formulation and Component Preparation Area.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Project Leadership & Delivery: Lead end to end delivery of Formulation and Component Preparation Area from design through construction, CQV, and handover to operations.
• Develop and manage project scope, schedule, cost, risk, and resource plans, ensuring alignment with business objectives.
• CrossFunctional & Stakeholder Management: Act as the primary interface between ETA technical leads, site engineering, manufacturing, quality, EHS, digital, and supply chain.
• Coordinate and align equipment vendors, engineering firms, and contractors to ensure delivery against agreed milestones and quality standards.
• Compliance, Quality & Safety: Ensure project execution complies with cGMP, EHS, and corporate engineering standards.
• Support and oversee CQV activities, ensuring readiness for commercial operation.
• Promote a strong safety culture throughout design, construction, and commissioning phases.
• Financial & Risk Management: Manage capital budgets, forecasts, change control, and cost reporting.
• Proactively identify and mitigate technical, schedule, cost, and compliance risks.
• Ensure effective vendor performance management and contract execution.
• Digital & Sustainability Focus:
• Integrate digital manufacturing, automation, and data strategies into project delivery.
• Champion sustainable design choices, energy efficiency, and resource optimization in line with sustainability goals.
• Any duties as assigned.

What you need to apply:

• 3-5+ years of experience in capital project delivery within the biopharmaceutical, pharmaceutical, or highly regulated manufacturing industry.
• Proven experience managing end-to-end facility or manufacturing area projects (concept through design, construction, CQV, and operational handover).
• Demonstrated experience delivering projects within GMP-regulated environments.
• Experience managing capital budgets, cost forecasting, changing control, and risk management for complex projects.
• Excellent communication and stakeholder management skills in a collaborative, matrixed environment.
• Direct experience supporting or overseeing Commissioning, Qualification, and Validation (CQV) activities.
• PMP (Project Management Professional), Chartered Engineer (CEng), or equivalent professional certification is desirable but not required.  
• Bachelor’s degree in engineering (Chemical, Mechanical, Electrical, Biochemical, Process, or related discipline).
• Advanced degree (MSc, MEng, MBA) is desirable but not required.

The Client provides a range of professional, technical, project management, property, fire & safety, and related services in respect of the procurement, development, operation, and maintenance of buildings, plant, and equipment. These services include design, specification, project management, supervision, and procurement associated with building and refurbishment works in the Cork /Kerry region.

Why you should apply:

• They put their people first and live their diversity and inclusion values embracing all perspectives.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

What you will be doing:

• The Fire Prevention Officer will be responsible, in respect of such premises and locations as may, from time to time be assigned to them for the following.
• Advise on the suitability of equipment to reduce risks within the organisation, trying where possible to standardise products in consultation with the organisation Procurement Team.
• Report as required to managers and relevant committees on areas of fire and infrastructural risk where action is required.
• Receive copies of accident reports relevant to their area of expertise, and action/investigate, if necessary. Providing accident investigation reports for accidents investigated
• Be a member of the organisation’s Integrated Quality and Risk committee, and where necessary be co-opted onto other groups as necessary.
• Monitor and report on the health and safety performance of external contractors engaged on Construction related activity on the organisation’s premises.
• Assist in the setting up and amendment of Emergency Plans.
• Provide an input into planning the expenditure in relation to Fire Safety by highlighting and prioritising essential works required.
• Regular inspections of buildings, means of escape and all fire-fighting equipment and ensuring that all such equipment is properly located, well-marked, in good repair and in good working order.
• Reviewing and, as necessary, drawing up of fire orders, including evacuation schemes for the various types of building and institution, including schemes for evacuation of all persons with particular regard to mentally ill and non-ambulant patients and to draw up fire plans of all the organisations buildings and premises in his / her area of responsibility.
• Regular and routine inspection of places, premises and equipment, which present a special risk of fire and reporting any breaches of the fire prevention code.
• Instruction of staff in each premises in: Avoidance of fire hazards, Summoning of the fire brigade, Operation of the fire alarm and fire equipment, and means of escape.
• Curtailment of an outbreak of fire, pending the arrival of the fire brigade, prevention of smoke spread and evacuation of danger areas.
• Arranging regular fire drills in each location and ensuring that they are properly carried out.
• Monitoring, by having regular tests carried out, the water supply in all divisions of each institution, to ensure that it is of sufficient volume and pressure for firefighting purposes and reporting any deficiencies in this regard. 
• Ensuring that all hydrants are clearly identified.
• Advising as appropriate regarding interpretation of Fire Protection Standards and Building Regulations issued by the Government Departments and ensuring their implementation.
• Monitoring all means of escape to ensure that they are always both safe and adequate and, kept operative and clearly indicated.
• Keeping proper records of all inspections, fires, evacuation drills, fire-fighting equipment and such other matters relating to his/her office as Fire Prevention Officer.
• Reporting in writing, to the Engineering Manager, at three-monthly intervals on the state of the fire prevention services in the organisation buildings and premises assigned to him/her.  Also, report immediately all outbreaks of fire, breach of the fire prevention order and failure to perform fire drill at the Organisations buildings and premises.  If so directed, the Fire Safety Officer will make out an annual report on all aspects of fire and safety pertaining to the organisation’s property in their area of responsibility.
• Arrange to have the fire prevention work programmes implemented under the direction of the Engineering Manager.
• Monitor and report on the management of Health Safety and Infrastructural Risk issues of the organisation.
• Assess the continuous professional training requirements for staff in the area and advise the Engineering Manager of the appropriate training courses and coordinating with the training providers on the course provided.
• Engage in the organisation’s performance achievement process in conjunction with your Line Manager and staff as appropriate.
• Monitor the performance and implementation of the organisations Safety Management programme by regular spot checks, by analysis of safety audit reports and accident and incident returns.
• Act as an information source and resource to management and staff on fire safety, general safety, health and welfare matters.
• Advise, guide and participate in the risk assessment process/inspection within the area of fire maintenance and infrastructural risk.
• Assist in the development of health and safety training programmes for maintenance staff which are to be harmonised throughout the company.
• Adequately identifies, assesses, manages and monitors risk within their area of responsibility.
• Support, promote and actively participate in sustainable energy, water and waste initiatives to create a more sustainable, low carbon and efficient health service.
• Achievement of targets and plans and completion of agreed programme within allocated budget.
• Act as spokesperson for the Organisation as required.
• Demonstrate pro-active commitment to all communications with internal and external stakeholders
• Develop good working relationships with other members of the team and with administrators of institutions in which maintenance staff are engaged

What you need to apply:

• Hold a HETAC level 7 qualification (NQF) in engineering, fire engineering, architecture, Health and Safety or Building Services/Building Survey. Or hold an equivalent qualification.
• Have two years’ experience in comparable Fire and Safety role.
• And Have a high degree of proficiency / expertise in Microsoft office.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Safely coordinate and lead cross functional project teams for the delivery of processing equipment to the site based on planned timelines and scope. Processing equipment would include e.g., Autoclaves, RABS & Isolator Filling machines, LAF units, Compounding skids, Vessels, Containment booths & Stopper processing equipment.
• Writing User Requirement Specifications.
• Selecting Vendors and completing Vendor evaluation matrix
• Writing RCE's, placing orders, Project Management & Design review meetings.
• Working to the ASME BPE 2019 Standard and relevant ISPE Guidelines etc.
• Coordination of processing equipment installation and services hook up, working with Equipment Vendors and Engineering personnel.
• Lead the Project Team participation in Factory Acceptance Testing program.
• Coordination of all equipment documentation requirements.
• Commissioning of equipment and Engineering support during qualification.
• Work with the E&T Senior Manager & System Owner / Project Team.
• Handover training, coordination of O&M manuals, Spare parts, & PM schedules.
• Contribute to a team environment on specific technical problem-solving forums associated with Product manufacture & Aseptic fill.
• Deliver on Process improvement / cost reduction projects.
• Lead your regular weekly / bi-weekly Project review meetings with your Project team.
• Attend the weekly Tier 1 meeting with your manager.
• Any other duties as assigned.

What you need to apply:

• Third level qualification in an Engineering or equivalent discipline/experience.
• Experience of working in Biologics, Pharmaceuticals or Medical device industry. Minimum of 2 to 5 years’ experience.
• Project Management experience with a proven record.
• Assured self-starter with proven technical ability.
•  Good communication and Interpersonal skills required to operate in a multi-function project team set up.
• Ability to work within a team using your own initiative to articulate and deliver specific functional requirements for all aspects of the project and work with members of various disciplines and functions across the project.
• Good team leading skills and ability to work closely with other areas/departments within an organization.
•  Culture fit: Have a people centred approach in a team environment whilst upholding the values and ethos of the company.
• Undertake any travel that the role may require for design review meeting, build inspections, Factory Acceptance Tests (FAT’s) etc.

Why you should apply:

• You will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards.
• Join a company where imagination and passion,  design and engineering find transformative solutions that turn dreams into possibilities.

What you will be doing:

• Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with core team members and extended quality functions as needed for the project.
• Contribute to the formation and ongoing management of DHF documentation
• Lead risk management activities within the project.
• Drive compliance management activities (e.g., IEC 60601) on the project with support from the Compliance Engineer.
• Demonstrate a patient-first approach to quality engineering.
• Support the creation and implementation of verification and validation activities.
• Work closely with R&D functions to ensure comprehensive testing of product requirements and the execution of the V&V plan.
• Review and approve testing procedures and documentation.
• Review and challenge the statistical rationale and data analysis within the test protocol and reports.
• Assess and authorise related execution deviations.
• Assist/conduct Failure investigations and problem-solving sessions.
• Responsible for the software issue tracking process per IEC 62304 to ensure software issues are logged, risk assessed and dispositioned appropriately.
• Ensure compliance across projects for design control, risk management, and change control processes.
• Advocate for a strong quality culture within project core teams
• Support of other QMS activities outside of projects, such as CAPA, Field Assessment and operations engineering assessments.

What you need to apply:

• A relevant degree or equivalent experience (engineering degree preferred), or a minimum of 5 years of quality engineering experience as an equivalent qualification 
• Knowledge in working with ISO 13485, QSR, ISO 14971, and statistical techniques
• Expertise in design assurance, including design controls, standards compliance, and risk management
• Strong written and verbal communication skills 
• Strong organisational skills 
• Experience with MDR – advantage 
• Experience with IEC 62304 and IEC 62366 – advantage 
• Ability to influence. 

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• Excellent contracting rates on offer.

What you will be doing:

• Minimum of 10 years’ experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in Cleaning Validation of cell culture unit operations and/or downstream unit operations.
• Previous experience of cleaning cycle development or cleaning cycle improvement in a technical role is advantageous.
• Proven expertise in leadership including demonstrated ability to drive for results and lead innovation and change.
• Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
• Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
• Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
• Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements.
• Ability to drive for results independently and adapt to rapidly changing priorities.
• Experience of leading Cleaning Validation teams is advantageous.
• Excellent communication skills, and able to effectively influence across all levels of the organization both internal and external.
• Detail orientated.
• Technical writing competency.
• Self-driven, able to prioritize, and to orchestrate multiple activities at once.
• Consistently demonstrate sound business judgment when making decisions.
• Ability to deal with ambiguity and complexity and influence others across levels of the organization

What you need to apply:

• Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
• An advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field is desirable.
• Experience of authoring CMC sections of regulatory submissions 
• Previous leadership experience of Cleaning Validation activites

Why you should apply:

• A job where you will find purpose and pride, where your work makes a difference.
• Join a team driven by a culture of courage, trust, and collaboration where you strive for efficient and effective operations
• Competetive Salary & benefits package

What you will be doing:

• Ensure the  site follows Good Manufacturing Practice for Medicinal Products for Human Use. This is according to Eudralex Volume 4 of "The rules governing medicinal products in the European Union." Follow Commission Directive 2003/94/EEC, its amendments, and any company requirements.
• Act as a Qualified Person (QP) responsible for implementing the quality management system. Lead all aspects of the products release process. Ensure strict adherence to regulatory and customer requirements.
• Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential product quality issues.
• Develop and maintain an internal review process to ensure continuous compliance, preparing the site for audits at any time.
• Lead and manage the audit process for the facility, ensuring that audit findings are thoroughly investigated and addressed promptly.
• Measure and analyze site quality metrics and indicators, comparing performance against targets, and implement data-driven actions for continuous improvement of processes and products.
• Develop and implement risk management strategies to minimize product and process risks, ensuring patient safety.
• Coordinate the management, execution, and approval of quality documents and records for the site, including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Report

What you need to apply:

• 6-10 years’ experience of Quality implementation in Pharma industry
• Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments.
• Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management.
• Proven leadership experience with a track record of consistently meeting results.
• Ability to operate effectively in a fast-paced environment and prioritize multiple tasks.
• Proven ability to manage/supervise a large and diverse team of employees.
• Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective.
• Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making.
• Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other functions.

Seeking an experienced System Owner Engineer (SOE) to lead the implementation and operational readiness of syringe filling equipment and associated single-use systems as part of a major site expansion in Dublin.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• This is a critical role supporting a high-speed, GMP-regulated fill-finish manufacturing environment.
• Act as System Owner (SO) for syringe filling equipment from design through to PQ and commercial operation.
• SO during equipment implementation, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and validation activities.
• Drive manufacturing readiness, start-up, and handover to operations.
• Ensure compliance with GMP, regulatory, and company global standards.
• Develop and implement: Maintenance strategies, Critical spare parts strategy, Preventive, maintenance programs and Lifecycle asset management plans.
• Provide technical leadership during deviation investigations, troubleshooting, and performance optimisation.
• Partner cross-functionally with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering.
• Support new product introduction and technology transfer activities.
• Any other duties as assigned.

What you need to apply:

• Bachelor’s Degree in Mechanical, Electrical, Chemical, or related Engineering discipline.
• 5+ years’ experience in biopharmaceutical manufacturing engineering.
• Proven experience in aseptic syringe filling systems (high-speed lines preferred).
• Strong knowledge of: GMP and regulatory expectations Annex 1 Aseptic processing principles Equipment validation lifecycle Experience with single-use technologies in fill-finish environments desirable.
• Demonstrated ability to lead complex equipment projects from design through operational readiness. Strong troubleshooting and root cause analysis capability.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing site.

What you will be doing:

• Co-ordinate and/or execute internal and external review and approval of all Laboratory related documentation.
• Proactively progress documents through all stages to achieve schedule timelines and in accordance with site policies & in compliance with cGMP’s.
• Be a reliable point of contact for the laboratory area for clear and precise communication of the documentation process and status of documents.
• To co-ordinate processing of laboratory documents into and out-of ABB Documentation systems.
• A key member on the laboratory readiness team during NPI, TT and routine Manufacturing, interfacing with all stakeholders to ensure the laboratory documents are prepared, executed and post approved in line with best practices and relevant timelines.
• Ensure highest Quality & Compliance standards.
• Track and trend relevant laboratory and business process metrics to ensure the laboratory are performing effectively and efficiently.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
  • Support the generation of efficient, user friendly documentation including SOPs
• Assist in the preparation of progress reports/presentations as required.
• Revise, update, and format documentation including SOPs, forms, logbooks.
• Write/review laboratory documentation (SOPs & Logbooks) ensuring it is current, accurate and in accordance with regulatory requirements.
• Will act as an SME for the laboratory function and also the wider organization in adherence to GDP guidelines.
• Will be flexible to take on additional tasks and responsibilities at the discretion of their manager.
• Applies knowledge, experience, and technical skills to understand laboratory objectives, to provide support to laboratory initiatives, to execute processes and procedures efficiently and compliantly, evaluates documents for improvement potential.
• Use standard practices to ensure inter-group consistency. Works, within established systems to improve Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) compliance across the laboratory department.
• Schedules and execute tasks, with limited assistance, to support laboratory schedule timelines.
• Circulates documents to reviewers and approvers with limited assistance, responds to comments and questions and coordinate referrals across the cross functional groups.
• Manages document review and approval to meet schedule timelines.
• Exercises judgment within generally defined procedures and practices to determine appropriate action.
• Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems.
• Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.
• Investigates Documentation related events in production that have quality or compliance impact.
• Leads or participates IIA, RCI sessions.
• Documents investigation outcomes.
• Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
• Comply with policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.
• Manage the laboratory Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting.

What you need to apply:

• • Bachelor’s Degree or equivalent preferential, preferably in a Science or related field
• Experience Level = 1+ Years
• Experience in a regulated laboratory setting. 
• Minimum of 1 year document control and records management experience in a regulated industry is strongly preferred. 
• Expertise with Microsoft Word with a solid understanding of the review and formatting tools is required. 
• Expertise with Outlook, Visio, Excel, PowerPoint is required. 
• Expertise in proofing and editing controlled documents for spelling, grammar, formatting and cGMP compliance is required. 
• Experience with the use of electronic systems to manage, edit and control documents is preferred.
• A proven track record executing, reviewing and approving GMP documentation to the highest GDP Standards
• Previous experience in a fast-paced and deadline driven environment is required

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing site.

What you will be doing:

• Ensuring Analytical Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
• Understanding Regulations and business processes required to maintain Laboratory Data Integrity.
• Ensuring timely completion of all laboratory analysis assigned to shift.
• Ensuring that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
• Improving the overall efficiency and velocity within the assigned team.
• Identifying and implementing improvements in analytical practices using ‘Zero, Believe it, Achieve it’
• Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
• Identifying weaknesses in laboratory performance and working with the laboratory management to rectify.
• Supporting & initiating analytical OOS issues as they arise in a timely manner both through practical work and through the quality system.
• Ensuring 5S excellence is maintained across the Laboratory.
• Instilling a quality culture of Zero, Believe it, Achieve it amongst the laboratory team
• Ensuring that all laboratory test equipment is utilised and maintained correctly.
• Maintaining up-to-date, complete and precise records of all tests performed.
• Investigates Documentation related events in production that have quality or compliance impact.
• Leads or participates IIA, RCI sessions.
• Documents investigation outcomes.
• Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
• Comply with policies and procedures, Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.

What you need to apply:

• Bachelor’s Degree or equivalent preferential, preferably in a Science or related field
• Experience Level = 1+ Years
• Experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines
• Proven track record in an analytical role. 
• Proficient in using analytical equipment in a QC lab as well as troubleshooting.
• Knowledgeable in instrumentation such as UHPLC, SoloVPE, TOC, and Identification techniques.
• Experience in industry is essential.

Will be supporting a substantial construction projects in the Pharmaceutical Industry. Coordination of construction activities to deliver the projects against Safety, Quality and Schedule commitments.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Oversight and planning of construction works in tandem with site contractors, construction managers and facility stakeholders.
• Drive safe execution of works.
• Ensure timely delivery of construction tasks.
• Reporting and management of the construction deliverables.
• Participate and run daily whiteboard sessions to plan work
• Drive a safety culture through the project team. Ensure that projects are in compliance with site and corporate regulatory authority guidelines.
• Work with construction contractors to ensure work is planned in advance, materials available, staff on site and safe and thorough planning is carried out – review and approve RAMS, SPAs etc.
• Solution seeking to complex project phasing and execution issues. The Project Engineer will need to work with stakeholders to identify the optimum path forward
• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Role model safety leadership. Support a safe working environment by driving compliance with environmental health/safety practice, rules and regulations.
• Ensure projects are delivered with superior levels of environmental control, health and safety built in.

What you need to apply:

• Experience of working in a similar construction environment – large project on a Biopharmaceutical site beneficial.
• Knowledge of safety, GMP and environmental regulatory requirements.
• Demonstrated strong Communication and Leadership skills.
• Demonstrated ability to collaborate with stakeholders to achieve optimal outcomes. Ability to work to tight deadlines in a fast-moving environment

Why you should apply:

• Join a company who strive to have a remarkable impact on people's lives across several key therapeutic areas – and are committed to operating with integrity.

What you will be doing:

• Manage the monthly Sales & Operations Planning (S&OP) process and Long-Range Planning (LRP) process.
• Create and oversee detailed production schedules, considering both demand and manufacturing capacity.
• Foster and sustain productive working relationships with both internal teams and external partners to support collaboration and achieve organisational objectives.
• Monitor and control inventory levels to ensure materials and products are available to meet production and customer needs, while reducing excess stock and related costs. 
• Develop and analyse supply chain scenarios. 
• Lead capacity planning and inventory management activities.
• Support all planning functions, including Master Production Schedule (MPS) and Material Requirements Planning (MRP).
• Track and report planning and operational performance metrics.
• Participate in network-wide supply chain activities to enhance integration and service.
• Drive and implement continuous improvement initiatives for planning processes.

What you need to apply:

• Bachelor’s degree in a relevant technical or business field.  
• Minimum of 6 years’ experience in manufacturing or supply chain environment, in a planning role.   Proficiency in MRP/ERP tools, especially SAP.  
• Demonstrated leadership abilities.  
• Effective communication and interpersonal skills, fostering collaboration across diverse functional teams.  
• Commitment to adhering to safety, regulatory, and quality standards in all planning operations.
• Proven problem-solving skills and the ability to develop and adapt strategies for changing business environment

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Environmental Monitoring of Grade 8/9 Cleanrooms
•  Environmental Monitoring of Grade 5/7 Cleanrooms & Isolator
• Reading of Environmental Monitoring Plates
• Bioburden testing of water & disinfectants
• Writing technical reports
•  Water sampling
• Testing of In Process samples such as Density & pH
• Technically strong background in microbiology and aseptic manufacturing
• Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
• Flexibility – the EM role often encounters changing priorities on a daily basis
•  Demonstrated leadership and communication skills
•   Auditing documentation and operation process
• Demonstrated ability to interact with regulatory agencies

What you need to apply:

• Bachelors degree in a science discipline 
• Biopharmaceutical QC experience in a microbiology lab 
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
• Experience working in an aseptic cleanroom performing Environmental Monitoring
• Proficient in the use of LIMS & LMES

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Endotoxin testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug product samples
• Sterility testing
• Water sampling
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation,

Identifications and Autoclave.

• Writing technical reports
• Media fill reconciliation and inspection
• Weekend bioburden cover
• Perform analytical testing as a main priority with efficiency and accuracy
• Report, evaluate, archive, trend and approve analytical dat
• Troubleshoot, solve problems and communicate with stakeholders
• Initiate and/or implement changes in controlled documents
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope
• Write protocols and perform assay validation
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.?

What you need to apply:

• Bachelors degree in a science discipline
• Biopharmaceutical QC experience in a microbiology lab?
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products? 

Team Horizon is seeking a Opex Business Analyst for a client in Cork. This person will be responsible for designing, developing, and maintaining digital dashboards that provide insights and data visualization to support business decision-making and performance improvements.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• You enjoy working on exciting projects and want to work with a global manufacturing site.

 What you will be doing:

• Gathering requirements from stakeholders and understanding their data visualization needs.
• Designing and developing interactive dashboards using company approved digital tools such as Power BI.
• Creating data models and connecting to various data sources to extract and transform data.
• Implementing data visualization best practices to present data in a clear and meaningful way including drill-throughs and analytical capabilities.
• Collaborating with data analysts and business users to ensure the accuracy and relevance of the data displayed in the dashboards.
• Optimizing dashboards for performance and usability.
• Creating and publishing reports and dashboards to the Digital Tool such as Power BI for sharing with stakeholders.
• Providing training and support to end-users on how to use and interpret the dashboards.

 What you need to apply:

• 18 month’s experience in one or more of the following: Basic C++, PowerApps, PowerBi, Power Automate, JSON, HTML, Dataverse, SQL Server, SharePoint, Relational Database Management
• Experience with Visual Studio, Visual Studio Code, Power Platform CLI - JavaScript, TypeScript, React JS, Python Deliverables include, but are not limited to: - Metrics Dashboards - Balanced Scorecard Reports
• Qualification Reports
•  Automation usage statistics
•  Integrated Survey and Reporting tool
•  Training Delivery
• Good understanding of data analysis and visualization principles, as well as strong problem-solving and communication skills.

Clean Utilities Engineer with previous relevant experience of Pretreatment Systems, Clean Steam, WFI and Process Air generation and distribution systems, to provide client side design input at Detailed Design, Commissioning, Qualification and handover stages of a design project for a Fill/Finish Building.
The scope of the role also includes design input and support during the project phases for various ancillary areas such as the existing Warehouse, a new -30Deg Coldroom, Laboratory reconfigurations and general site infrastructure.
The position is a hybrid position with an on-site (3 Days) and remote working element.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• To support the client side design team in its efforts associated with the expansion project.
• To provide technical expertise working with other project stakeholders, in order to achieve design deliverables.
• To track, manage and communicate adherence to discipline project milestones.
• To coordinate client side clean utilities (Clean Steam / WFI / CA) design by liaising with Site SME’s and Engineering Technical Authority (ETA).
• To assist client side design reviews in the area of Clean Utilities for the expansion project.
• To participate in cross functional package, area, or overall design teams as required in support of overall design goals and expectations.
• To input into Technical Assessment in support of the instrumentation framework, and/or procurement agreements.
• To participate in design reviews, model reviews, etc., and to input on technical elements of the design.
• To execute Drawing, URS, HDS, SDS, Equipment & Instrument Specifications and other reviews associated with the Clean Utility installations.
• To participate in CMSAT’s / Loop checking, including any trouble shooting activities
• To provide input and assistance to Automation, C&Q and Validation in terms of equipment packages as required.
• To participate in the design reviews and specifications review of any Vendor Package Equipment in the new Facility.
• Provide attendance / assistance for FAT’s / SAT / C&Q and Validation activities at various locations, site or Vendor, as required.
• To provide input into the calibration program for clean utilities. To coordinate with site Metrology Group to ascertain calibration requirements and to ensure the execution of calibrations, both equipment and field instruments, in line with these requirements.
• To liaise with the site Maintenance Group and to ensure that any data gathering required to support the MAXIMO system requirements.
• To provide input / direction into schedule and cost discussions, as required, in order to meet the project objectives as defined by the Design Manager, Project Manager and Steering Committee, or designees.
• A site presence will be required during construction. This will involve oversight / supervision of the Clean Utilities element of the expansion project.

What you need to apply:

• Minimum of 5 years of experience in pharmaceutical design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design. Direct experience in a similar scale project.
• Ability to challenge, defend and present technical aspects of design and commissioning.
• Education Degree level qualification in Chemical / Mechanical Engineering, or similar/equivalent.

Why you should apply:

• They put their people first and live their diversity and inclusion values embracing all perspectives.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

What you will be doing:

• Ensures that the Test Data specified by the System Validation team is collected and delivered to stakeholders in time and with the required quality.
• Coordinates Data Collection activities for the project.
• Reports to Fleet & Operations team lead.
• Statistical test requirement analysis
• Data Collection plan contributor and reviewer
• Delivers the Data Collection Plan and maintains it
• Detailed plan of capturing according to each requirement of Data Collection Catalogue(Country, Route type, Weather conditions, etc.).
• Specific route planning updates of needed resources and services
• PRE-SOCO and SOCO process.
• Provides detailed efforts and costs estimations for all Data Collectionactivities
• Manages and executes the Data Collection:
  1) Preparation of vehicle transport and registration
  2) Services for legal aspect of capturing (e.g. Data Protection,GDPR )
  3) Hiring, Training and managing of driver crews & Shift planning.
• Ensures vehicle operations are followed as defined by the System Tools coordinator.
• Secures daily progress reporting vs plan. Evaluates current operational performance.
• Identifies problems in operations processes and works to resolve them in a timely manner.
• Maintains clear and accurate operations documents/procedures within a given project for reference purposes.
• Ensures compliance to internal or external rules, regulations and standards for data collection
• Any other duties as assigned.

What you need to apply:

• Degree: Bachelor’s Degree or Diploma in Computer Science, or a related technical discipline.
• Core Experience: Minimum of 2 years in a technical data management or operations role.
• Technical Advantage: A background in data scripting (SQL/Python), JIRA, Google Cloud Platform and is a significant advantage.
• Project management (Agile, Prince2) is highly regarded, but not essential.
• Data Formats: Familiarity with JSON, XML, and CSV structures used in automotive logging and toolchain configurations desirable but not essential.
• A self-motivated "demonstrable leader" who thrives in a dynamic, high-pressure R&D environment.
• Excellent presentation skills with the ability to articulate technical data status to diverse audiences.
• A mindset focused on optimizing processes and a proactive approach to problem-solving..
• Confident, energetic team player with the initiative to drive tasks to completion.
• A proven track record of maintaining exceptional levels of accuracy managing complex batch datasets, compliance documentation, and high-visibility workflow dashboards.

Why you should apply:

• You’ll work in a dynamic, collaborative environment where your ideas are valued, your voice matters, and your expertise directly shapes the future of the organisation.
• If you’re driven, curious, and ready for the next step, this role is where you can thrive

What you will be doing:

• Recruitment will be focused on a specific team/function, or other areas as assigned.
• Responsible for attracting top talent and developing a strong, qualified candidate pool for current and future openings.
• Additional job duties include pre-screening candidates, project management, partnering with team members to develop sourcing strategies and providing talent for open positions.
• Demonstrate ability to proactively identify, source and manage talent pools aligned to business priorities.
• Core responsibility is to manage open job requisitions, update and manage SmartRecruiters, achieve recruiting metrics and report key accomplishments.
• Will also compile and communicate the knowledge base, industry overviews, and market trends, data and analytics to team members and business leaders.
• Will prepare and approve offer packages, providing equity & market competitiveness data research.
• Ensure compliance to state/federal employment laws and policies and practices for applicant tracking compliance and reporting metrics.
• Establish a true business partnership with hiring managers and leadership on all staffing related activities and issues.

What you need to apply:

• Bachelor's degree required.
• 2-3+ years recruitment experience in a competitive, fast-paced environment required.
• Must project a strong business presence and have the ability to instill confidence in clients and to deliver results.
• Proactive recruiting and sourcing experience required.
• Healthcare/Pharmaceutical industry recruitment experience strongly preferred.
• Experience in managing requisitions within SmartRecruiters preferred.

Act as System Owner for key utility systems within the Site F&E (Facilities & Engineering) group.
The successful candidate will take full ownership of assigned systems, ensuring they remain safe, compliant, and operating at optimal performance. This is a hands-on, high-accountability role requiring the ability to work independently, engage cross-functionally, and maintain inspection readiness at all times.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Own day-to-day performance of assigned utility systems
• Monitor, trend, and optimise system performance and uptime
• Troubleshoot issues and implement timely, effective resolutions
• Co-ordinate and manage vendors and ensure preventive maintenance is executed effectively
• Maintain oversight of critical spare parts and asset reliability
• Identify and implement practical improvements to system reliability and performance
• Apply data-driven approaches to resolve recurring issues
• Support optimisation of maintenance strategies (preventive / predictive)
• Review and approve SOPs, change controls, and technical documentation
• Execute and manage CMMS work orders related to owned systems
• Rolling out training on systems and ensuring all documentation is accurate, current, and audit-ready
• Ownership of interactions, understanding of the interface of their systems with the BMS or PCS systems on site
• Lead and close out deviations, non-conformances, and CAPAs, including RCA ownership
• All design reviews associated with equipment purchases and review/approval of changes to their systems.
• Support Quality System triage activities.
• Ensure systems are maintained in an inspection-ready state and act as SME during audits and regulatory inspections.
• Interface with Manufacturing, QA, Labs, and EHS on system performance and issues.
• Provide clear technical input to support operational decision-making.
• Represent Utilities in cross-functional meetings as required.
• Support ongoing site projects as required.
• Contribute to development of execution FAT, SAT, and IOQ deliverables.
• Review and support system changes and upgrades.
• Any duties as assigned.

What you need to apply:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical or related).
• Strong experience in GMP-regulated pharmaceutical or biotech environments.
• Proven experience operating / troubleshooting utility systems (e.g. HVAC, WFI, clean utilities, process utilities).
• Demonstrated experience in deviations, CAPAs, and root cause analysis.
• Ability to work independently with minimal supervision.
• Previous System Owner / SME experience.
• Experience supporting regulatory inspections and audits.
• Familiarity with BMS / PCS / automation systems and understanding of the interface of their systems.
• Experience in GMP qualification (FAT/SAT/IOQ) and involvement in capital projects or site upgrades.

Why you should apply:

• This is an excellent opportunity to make an impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience.

What you will be doing:

• Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management.
• Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems.
• Lead batch review and release, documentation, checks, and test completion.
• Oversee validation of manufacturing and testing processes and accurate record keeping.
• Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications.
• Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches
• Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA).
• Chair Change Review Boards, approve changes, oversee completion of QA tasks.
• Conduct internal/external audits and participate in regulatory/customer inspections.
• Manage complaint investigations, coordinate product recalls, and address quality defects.
• Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and  QA Policies.
• Review and approve Product Quality Reviews (PQRs) and track finished product data.
• Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics.
• Act as Designee for the Quality Director when required.
• Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making.

What you need to apply:

• MSc in Industrial Pharmaceutical Science (or a comparable course recognized for QP status per Article 49 of Directive 2001/83/EC).
• Minimum 10 years' experience in the healthcare/pharma sector within FDA/EMA approved environments.
• Demonstrated experience leading teams, with 7+ years in leadership roles Demonstrated attention to detail, strong problem-solving and innovative thinking abilities.
• Results-driven mindset with proven prioritization skills and commitment to quality.
• High integrity, strong work ethic, excellent verbal/written communication, and interpersonal skills.

Team Horizon is seeking a Project Engineer (Syringe Inspection) for a client in Dublin who will support the installation, validation, and lifecycle management of automated syringe inspection systems within a GMP fill-finish facility expansion.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Act as System Owner (SO) for automated syringe inspection systems.
• SO during the FAT/SAT, commissioning, qualification, and validation activities.
• Ensure compliance with GMP, Annex 1, and data integrity requirements.
• Own system performance metrics including: False reject rates, Detection capability, OEE performance
• Support inspection recipe development and optimisation.
• Develop maintenance and lifecycle strategies for inspection equipment.
• Lead troubleshooting and root cause investigations for inspection failures.
• Support audit readiness and regulatory inspections.

What you need to apply:

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Automation, or related discipline).
• 5+ years’ experience in biopharmaceutical manufacturing.
• Experience with Automated visual inspection systems (AVI), Vision systems, High-speed packaging or inspection lines
• Understanding of particulate detection, cosmetic defect inspection, and container closure integrity.
• Experience supporting equipment validation and data integrity compliance.
• Strong analytical and problem-solving skills.

Team Horizon is seeking a Process Engineer (Senior) for a client in Dublin who will provide technical support to large molecule and small molecule drug product manufacturing as well as part of the global Process Development (PD) organization. 

 Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Developing single use systems in collaboration with site teams and network for DP formulation and filling.
• Authoring / verification of single use qualification packages.
• Filling characterisation support (Filling recipe development - protocol development / execution and reporting.) 
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.
• Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
• Provide process development expertise for drug product processing in specific areas such as sterile processing, process characterization, filling, SUS. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
• Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine root cause.
• Lead or assist in deviation / exception resolution and root cause analysis.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
• Review and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Contribute to product quality assessments and process flow documents.
• Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process.

What you need to apply:

Basic Qualifications:      

• A third level Bachelor’s Degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Thorough knowledge of aseptic manufacturing technologies and cGMP.
• Problem solving ability and excellent oral and written communications skills
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Formulation Single use systems and Filling.

Preferred Qualifications:

• 10 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of formulation, mixing, filtration and filling.  Knowledge of protein biochemistry regarding chemical and physical stability
• Background in Drug product Filling technologies, Peristaltic pumping / Time pressure filling.   
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role.

Team Horizon is seeking a MES Engineer for a pharmaceutical client in Sligo. This person will be supporting multiple projects within MES across Medical Device and Biologics divisions. 

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Support SAP and MES strategy.
• Continuously review and manage business risk associated with POMSnet system and recipes.
  Continuously review and ensure all business processes, including SOPs, required to implement and manage SAP and POMSnet system changes and POMSnet recipe changes comply with current Safety, Quality and Information Technology policies.
• Continuously review and ensure all documented policies, procedures and training plans required to implement and manage SAP and POMSnet system changes and POMSnet recipe changes comply with current Safety, Quality and Information Technology requirements.
• Ensure the timely and compliant qualification of POMSnet recipes and upgrades aligned with business objectives.
• Support SAP business system as local key user (LKU) for POMSnet and material queries.
• Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
•  Resolves project/system/ recipe issues by working with team members, project customers, and others as appropriate.
• Responsible for systems compliance with quality related SOP’s.
• Promote a culture of perfect performance and right first time within their team.
• Required to front audits by HPRA/FDA or Customers on SAP and MES.
• Participate in MES knowledge exchange with MES and other sites
• Participate in MES Technical Review Board (TRB) Meetings, and manage issues, workarounds and fixes identified.
• Participate in projects from initiation to ensure MES system or hardware requirements are understood and taken into consideration.

What you need to apply:

• Demonstrated working knowledge of Manufacturing Execution Systems is required for this role.
• Relevant science/engineering or IT discipline OR Degree Relevant science/engineering or IT discipline
• A minimum of three years’ experience in an FDA/ HPRA regulated industry.
• A strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
• A good knowledge of the POMSnet or other MES system is required for this role.
• Experience of operating in a team environment with active participation in proactive improvement programs is required. 

Responsible for preparation of building the prototypes (A, B-samples, sub-components, test fi xtures) according to requests with accountability for the deliverables of his/her scope to ensure the success of the project (activities from RFQ phase to final customer acceptance). Will be reporting to the R&D Test Manager. Responsible for Product Validation activities from RFQ phase to final customer acceptance. that includes complex validation planning, execution, reporting and closure.

Why you should apply:

• They put their people first and live their diversity and inclusion values embracing all perspectives.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

What you will be doing:

• Track Prototype Requests across Product Lines for the Program.
• Realization and checking of the prototypes.
• Prototype coordination for the program including capacity planning and supplier management.
• Prepare additional component requests - (TIC’s Harnesses, Camera, cables).
• Flashing of software.
• Purchase Order tracking.
• Documentation/sample history (Prototype Control Plan, revision report).
• Rework instruction documentation.
• Manage component/sub-component inventory.
• Delivery to project, customer, Shipping and Dispatch Preparation & Tracking.
• Any other duties as assigned.

What you need to apply:

• A relevant Technical Engineering Degree e.g. Computer & Electronic Engineering, Physics & Instrumentation, Mechatronics, SW - Computer literate in MS Office/Google suite.
• Experience in automotive industry.
• Knowledge in electronics, mechanics and Automotive technologies.
• Proactive, team work, communication, goal oriented working Engineer with high experience in prototyping for automotive industry Team spirit.

Responsible for preparation of building the prototypes (A, B-samples, sub-components, test fi xtures) according to requests with accountability for the deliverables of his/her scope to ensure the success of the project (activities from RFQ phase to final customer acceptance). Will be reporting to the R&D Test Manager. Responsible for Product Validation activities from RFQ phase to final customer acceptance. that includes complex validation planning, execution, reporting and closure.

Why you should apply:

• They put their people first and live their diversity and inclusion values embracing all perspectives.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

What you will be doing:

• Track Prototype Requests across Product Lines for the Program.
• Realization and checking of the prototypes.
• Prototype coordination for the program including capacity planning and supplier management.
• Prepare additional component requests - (TIC’s Harnesses, Camera, cables).
• Flashing of software.
• Purchase Order tracking.
• Documentation/sample history (Prototype Control Plan, revision report).
• Rework instruction documentation.
• Manage component/sub-component inventory.
• Delivery to project, customer, Shipping and Dispatch Preparation & Tracking.
• Any other duties as assigned.

What you need to apply:

• A relevant Technical Engineering Degree e.g. Computer & Electronic Engineering, Physics & Instrumentation, Mechatronics, SW - Computer literate in MS Office/Google suite.
• Experience in automotive industry.
• Knowledge in electronics, mechanics and Automotive technologies.
• Proactive, team work, communication, goal oriented working Engineer with high experience in prototyping for automotive industry Team spirit.

The Client provides a range of professional, technical, project management, property, fire & safety, and related services in respect of the procurement, development, operation, and maintenance of buildings, plant, and equipment. These services include design, specification, project management, supervision, and procurement associated with building and refurbishment works in the Cork /Kerry region.

Why you should apply:

• They put their people first and live their diversity and inclusion values embracing all perspectives.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

What you will be doing:

• The Fire Prevention Officer will be responsible, in respect of such premises and locations as may, from time to time be assigned to them for the following.
• Advise on the suitability of equipment to reduce risks within the organisation, trying where possible to standardise products in consultation with the organisation Procurement Team.
• Report as required to managers and relevant committees on areas of fire and infrastructural risk where action is required.
• Receive copies of accident reports relevant to their area of expertise, and action/investigate, if necessary. Providing accident investigation reports for accidents investigated
• Be a member of the organisation’s Integrated Quality and Risk committee, and where necessary be co-opted onto other groups as necessary.
• Monitor and report on the health and safety performance of external contractors engaged on Construction related activity on the organisation’s premises.
• Assist in the setting up and amendment of Emergency Plans.
• Provide an input into planning the expenditure in relation to Fire Safety by highlighting and prioritising essential works required.
• Regular inspections of buildings, means of escape and all fire-fighting equipment and ensuring that all such equipment is properly located, well-marked, in good repair and in good working order.
• Reviewing and, as necessary, drawing up of fire orders, including evacuation schemes for the various types of building and institution, including schemes for evacuation of all persons with particular regard to mentally ill and non-ambulant patients and to draw up fire plans of all the organisations buildings and premises in his / her area of responsibility.
• Regular and routine inspection of places, premises and equipment, which present a special risk of fire and reporting any breaches of the fire prevention code.
• Instruction of staff in each premises in: Avoidance of fire hazards, Summoning of the fire brigade, Operation of the fire alarm and fire equipment, and means of escape.
• Curtailment of an outbreak of fire, pending the arrival of the fire brigade, prevention of smoke spread and evacuation of danger areas.
• Arranging regular fire drills in each location and ensuring that they are properly carried out.
• Monitoring, by having regular tests carried out, the water supply in all divisions of each institution, to ensure that it is of sufficient volume and pressure for firefighting purposes and reporting any deficiencies in this regard. 
• Ensuring that all hydrants are clearly identified.
• Advising as appropriate regarding interpretation of Fire Protection Standards and Building Regulations issued by the Government Departments and ensuring their implementation.
• Monitoring all means of escape to ensure that they are always both safe and adequate and, kept operative and clearly indicated.
• Keeping proper records of all inspections, fires, evacuation drills, fire-fighting equipment and such other matters relating to his/her office as Fire Prevention Officer.
• Reporting in writing, to the Engineering Manager, at three-monthly intervals on the state of the fire prevention services in the organisation buildings and premises assigned to him/her.  Also, report immediately all outbreaks of fire, breach of the fire prevention order and failure to perform fire drill at the Organisations buildings and premises.  If so directed, the Fire Safety Officer will make out an annual report on all aspects of fire and safety pertaining to the organisation’s property in their area of responsibility.
• Arrange to have the fire prevention work programmes implemented under the direction of the Engineering Manager.
• Monitor and report on the management of Health Safety and Infrastructural Risk issues of the organisation.
• Assess the continuous professional training requirements for staff in the area and advise the Engineering Manager of the appropriate training courses and coordinating with the training providers on the course provided.
• Engage in the organisation’s performance achievement process in conjunction with your Line Manager and staff as appropriate.
• Monitor the performance and implementation of the organisations Safety Management programme by regular spot checks, by analysis of safety audit reports and accident and incident returns.
• Act as an information source and resource to management and staff on fire safety, general safety, health and welfare matters.
• Advise, guide and participate in the risk assessment process/inspection within the area of fire maintenance and infrastructural risk.
• Assist in the development of health and safety training programmes for maintenance staff which are to be harmonised throughout the company.
• Adequately identifies, assesses, manages and monitors risk within their area of responsibility.
• Support, promote and actively participate in sustainable energy, water and waste initiatives to create a more sustainable, low carbon and efficient health service.
• Achievement of targets and plans and completion of agreed programme within allocated budget.
• Act as spokesperson for the Organisation as required.
• Demonstrate pro-active commitment to all communications with internal and external stakeholders
• Develop good working relationships with other members of the team and with administrators of institutions in which maintenance staff are engaged

What you need to apply:

• Hold a HETAC level 7 qualification (NQF) in engineering, fire engineering, architecture, Health and Safety or Building Services/Building Survey. Or hold an equivalent qualification.
• Have two years’ experience in comparable Fire and Safety role.

And Have a high degree of proficiency / expertise in Microsoft office.

Team Horizon is seeking a Quantity Surveyor Advisor in Dublin. The purpose of this role is to provide professional advice supporting the preparation, management, and delivery of the health capital program

They will also provide professional advice on all aspects of procurement, contract, and commercial related issues which related to the delivery of capital projects.

 Why you should apply:

• You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
• You enjoy working in a culture of learning and collaboration and making a positive impact.

 What you will be doing:

• Assist with the delivery of the Capital plan for the area in compliance with Capital Approval Protocols, Public Procurement requirements and the financial Regulations.
• Preparation of Capital submissions in accordance with Capital Approval protocols and Infrastructure Guideline requirements.
• Provide support and advice in strategic planning, briefing, construction, equipping and related matters
• Assist with the application of the Infrastructure Guidelines and the various requirements as set out in Guidelines at each of the Project Lifecycle stages as defined in the Infrastructure Guidelines to ensure value for money, the evaluation, planning and management of public investment projects.
• Provide all relevant procurement, contractual and commercial advice required to deliver the various capital projects being delivered within the area.
• Developing action plans for the timely and efficient completion of contracts. Co- ordinating the tender and control stages of projects, having close liaison with design teams, site supervisory staff, etc. on the one hand and hospital personnel on the other.
• Managing the necessary and appropriate consultation processes, meetings, and other activities necessary to satisfactory completion of the project.
• Managing the necessary and appropriate consultation processes, meetings, and other activities necessary to satisfactory completion of the project.
• Complying with all regulatory and statutory requirements including permission, licences, certificates, and approvals.
• Ensure all works are carried out in compliance with Health and Safety regulations.
• Supervising staff and contractors in the implementation of agreed programmes.
• Assist in the management of projects and helping to quickly resolve such issues as may be for resolution and agreement.
• Managing the processing, certification and controlling expenditure on each assigned project. This is to include presentations to the Principal Quantity Surveying Adviser and the local Capital & Estates teams as required, of information and current estimates of total costs, running statements of financial commitment and forecasts of expenditure
• Defining requirements for design services, buildings, and equipment.
• Procurement and selection of Design Teams, other professional services, and contractors for Capital Projects, arranging and managing the procurement processes.
• Obtaining approval to proposals as necessary in accordance with protocols and regulations in a timely manner.
• Developing proposals with selected design teams and contractors.
• Health estate planning, option studies, briefing, design development and project management with a view to optimising value related to best outcomes.

What you need to apply:

• Hold a Level 8 (or higher) Quality & Qualifications Ireland (QQI) major academic award in Quantity Surveying accredited by the relevant Professional Institute (Society of Chartered Surveyors in Ireland, Royal Institution of Chartered Surveyors).
• Be registered as a Quantity Surveyor or be eligible for registration as a Quantity Surveyor under the Building Control Act 2007. Have a full membership of or be eligible for membership of a relevant professional association.
• Have had at least 7 years’ satisfactory & relevant experience fulfilling the role of a Quantity Surveyor within either a contractor organisation or a private consultancy business.
• Candidates must possess the requisite knowledge and ability (including a high standard of suitability and of administrative capacity) for the proper discharge of the duties of the office.  
• Membership of the relevant professional association:  Society of Chartered Surveyors in Ireland / Royal Institution of Chartered Surveyors 
• Candidates should have full, professional membership i.e. be a chartered member of the Society of Chartered Surveyors in Ireland and or Royal Institute Chartered Surveyors (Quantity Surveying)    
• Good Knowledge and Experience of the design and construction and maintenance requirements of buildings and building services.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
• Excellent contracting rates on offer.
• They put their people first and live their diversity and inclusion values embracing all perspectives.

What you will be doing:

• Communicate daily the results of tests performed
• Ensure the quality of the tests performed and the correct analysis 
• Verify that the samples and all additional equipment are compliant to the request
•  Write reports and verify reports from other members
• Respect the processes defined to be compliant to INAB accreditation
• Declare any process malfunction with the QRQC tool, and put in place the right corrective actions 
• Participate actively to continuous improvement
• Activity follow up and Reporting
• Respect the objective defined for the setup time
• Ensure the delivery of reports in time, at the good quality level

What you need to apply:

• Technical Training Diploma/Degree e.g., Electronic Training, Physics & Instrumentation, Mechatronics.
• Have Technician experience in Electronics / RF microwaves
• At least 2 years in EMC testing. 
• Junior technician can be accepted if he/she shows good mindset / motivation.

This QC framework defines the working standards candidates will operate within.

Scientific Disciplines in Scope

1. Analytical Chemistry / QC Chemistry

• HPLC / UPLC assay & impurity testing
• GC analysis (residual solvents)
• Dissolution testing
• Karl Fischer / moisture content
• Method verification and transfer support
• Stability testing (ICH conditions)

2. Microbiology / Environmental Monitoring

• Bioburden and microbial limit testing
• Sterility testing (where applicable)
• Endotoxin testing (LAL)
• Environmental monitoring (viable & non-viable)
• Water system monitoring (PW/WFI)
• Media preparation and growth promotion testing

3. Bioassay / Cell-Based Testing

• Cell culture maintenance and aseptic handling
• Potency assays (in vitro bioactivity testing)
• ELISA / ligand-binding assays
• Reference standard qualification support
• Assay validation and trending
• Data analysis and variability control

4. Analytical / Data & Instrumentation Support

• Instrument calibration verification
• System suitability testing
• Chromatography data review (CDS systems e.g. Empower)
• Audit trail review and data integrity checks
• Method troubleshooting and optimization support

Team Horizon is seeking a Reliability Engineer for a client in Mayo who will be supporting the Maintenance Excellence Program (MEP) through advanced reliability engineering methods. 

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Develop a reliability road map for own business unit and receive endorsement from the Senior Leadership Team.
• Drive reliability culture by leading Reliability Centred Maintenance, Root Cause Analysis, Preventive Maintenance Optimisation and Reliability Improvement Project initiatives.
• Evaluate and expand the predictive maintenance program to identify and prevent emerging failures and maintain a rolling yearly log of cost savings.
• Analyse highly automated machinery to generate a top 10 bad actor profile and identify, execute and report on actions taken for the top 3 high value detractors.
• Link actions to financial benefit and align priorities with the largest opportunities for the business.
• Build strong relationships with Global Engineering and local engineering and maintenance teams.
• Be a key contributor in the reliability engineering community of practice and smart maintenance initiatives.
• Ensure compliance with policies, procedures and regulatory standards.
  Champion good EHS practices and support the site safety culture

What you need to apply:

• Third-level qualification in Engineering.
• 3+ years experience within a regulated and/or highly automated environment. Strong data analytics skills.
• Reliability engineering and continuous improvement experience and/or certification desirable. (Green belt and/or CMRP or CRL preferred).
• Demonstrated ability to analyse machinery, conceptualise, implement and quantify significant improvements in OEE.

Why you should apply:

• This role will provide you the opportunity to get exposure to a broad range of validation activities on site, and you
• You will be responsible for co-ordinating the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements.

What you will be doing:

• Co-ordinate, implement and participate in the site Validation Program.
• Ensure all computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
• Co-ordinate / direction and participate in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
• Generate/maintain Validation Master Plans.
• Generate /maintain Project Validation Plans.
• Generate validation plans, write protocols and final reports to cGMP standard.
• Review / approve of protocols and final reports as required.
• Manage validation change control process.
• Adhere to and support all EHS & E standards, procedures and policies.

What you need to apply:

• 3rd level qualification in a relevant engineering or scientific discipline.
• A minimum of 2 years’ experience in a cGMP regulated pharmaceutical manufacturing environment.
• High level of attention to detail and mental concentration, to ensure accuracy and compliance. Excellent communications skills with the ability to write protocols and reports. 
• Proven problem-solving skills and the ability to adapt to new regulatory requirements.

This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. This will involve partnering with major stakeholders such as Manufacturing, QC, QPs, Technical services, Engineering and Planning to optimize patient supply.

Why you should apply:

• Join a team who unleash bold thinking with the power to inspire life-changing medicines.
• Hybrid role with a mix of in-person working to give a platform to connect, work at pace and challenge perceptions with balance of remote working 2 days per week.

What you will be doing:

• Quality Oversight for new product introduction in Bulk Drug Substance facility.
• Quality oversight for new or modified facilities, equipment, technologies, including analytical, as well as other continuous improvements and requalification’s.
• Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating manufacturing
• Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, Equipment and others.
• Review and approval of qualification/verification/validation documents for facilities, equipment, processes, analytical methods, suppliers, software and others. (e.g. URS, Facility, Utility, IT Systems, Test Methods, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.
• Quality oversight on operations and technical services to review and approve Process descriptions , sampling plans, operational procedures, process validation and cleaning validation documents
• Review and Approve TRA’s, MSRs, SAP requests related to new products .
• Provide QA support for supplier qualifications.
• QA review all analytical facility, equipment and method qualifications and validations.
• Ensure all Materials are sampled and released as per the approved specifications and procedures .
• Investigation and approval of deviations generated encountered during qualification/validation testing.
• Participation in the project change control program and deviations for modifications to new and existing systems. equipment.
• Provide guidance to project teams on Quality regulations for Validation strategy and approach.
• Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups.
• Provide sound QA and Compliance support to manufacturing, engineering, automation, utilities, supply chain, and material movement and laboratories.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
• Actively support audit readiness activities and regulatory agency and internal audits.

What you need to apply:

• Third level qualification e.g. B.Sc. in science/pharmacy or equivalent with a minimum of 6-8 years’ experience in cGMP Quality environment
• Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing.
• Excellent accuracy and attention to detail
• Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault or similar
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
• High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.
• Previous QA experience aligned to Technical Services, Engineering/CQV reviews, operational (batch records, procedures), supplier qualification, packaging lines, warehousing (including temperature mapping of, along with fridges and freezers) and QC analytical qualifications/validations and laboratories of particular interest.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written

Team Horizon is seeking an Operational Readiness Sr Associate for a client in Dublin who will be responsible for ensuring operational readiness by supporting cross-functional execution across all major milestones.

The person in this role will enable day-to-day execution by coordinating inputs across Manufacturing, Quality, Engineering, EHS and other stakeholders, ensuring dependencies are understood, decisions are actioned, and readiness activities remain on track. The Operational Readiness Sr. Associate will monitor compliance and adherence metrics.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Support operational readiness planning and execution across all key milestones.
•  Maintain a forward-looking view of execution needs (12–18 months) to ensure equipment, commissioning, qualification and manufacturing preparedness activities are sequenced to enable safe start-up and reliable operations.
• Align Manufacturing, Quality, Engineering, EHS and other functional readiness plans into a single execution rhythm, ensuring handoffs, constraints and critical dependencies are understood and actively managed.
• Provide clear visibility of readiness status, identify operational risks and escalate emerging issues to maintain compliance, safety and reliability.
• Establish consistent ways of working for readiness reviews, decision logging and action closure to keep teams aligned and accountable.
• Establish and enforce structured progress tracking mechanisms across all workstreams.
• Ensure timely updates from functional teams and validate accuracy of reported progress, track milestone readiness and ensure alignment with overall project timelines.
  Hold teams to account through identifying performance gaps and drive accountability with stakeholders.
• Support regular reporting cycles with accurate, data-driven insights, proactively identify schedule risks, bottlenecks, and dependency conflicts.
• Escalate risks that could impact critical milestones such as Media Fill or PPQ and should partner with stakeholders to define mitigation plans and track resolution.
• Ensure all functions are aligned to a single integrated schedule and planning framework and act as a central coordination point for schedule-related decision-making.

What you need to apply:

• Strong understanding of project lifecycle phases (commissioning, qualification, etc.).
• Ability to manage complex, cross-functional dependencies.
• Strong analytical and problem-solving skills.
• Excellent stakeholder management and communication skills.
• AI mindset
• Prior Manufacturing experience or relevant experience in pharma/biotech or large-scale project environments preferred.

Team Horizon is seeking a Commissioning Lead in Dublin. The Equipping and Commissioning Lead will be responsible for coordinating and providing a range of clinical and non-clinical equipping services, and advice in the context of delivering a fully integrated sourcing and logistics service for the project. 

Why you should apply:

• You enjoy working in a culture of learning and collaboration and making a positive impact.
• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

What you will be doing:

• Lead equipping and commissioning activities for the programme workstream.
• Develop and implement equipment procurement and commissioning strategies.
• Coordinate equipment specifications, procurement evaluations, and contract awards.
• Drive value-for-money initiatives and cost-saving opportunities.
• Align procurement activities across multiple workstreams and stakeholders.
• Manage risks, assumptions, issues, and dependencies (RAID).
• Support readiness assessments and Go/No-Go commissioning decisions.
• Ensure compliance with health & safety, and sustainability standards.
• Work collaboratively with internal teams, contractors, and external stakeholders.

What you need to apply:

Essential Requirements:

• Level 8+ qualification in Architecture, Engineering, or Surveying accredited by a recognised professional body, or full professional membership (Engineers Ireland, RIAI, SCSI, RICS).
• Proven experience managing procurement and commissioning on large, complex projects.
• Strong knowledge of project management, procurement, construction, and building services.
• Understanding of healthcare environments, HIQA standards, and public procurement processes.
• Experience in risk management, reporting, budgeting, and stakeholder management.
• Excellent communication, leadership, planning, and organisational skills.

Preferred Skills

• Knowledge of healthcare facility design, maintenance, and compliance standards.
• Professional project management certification (PRINCE2, CAPM, or equivalent) desirable
• Ability to manage multidisciplinary teams and deliver results in fast-changing environments.
• Strong problem-solving, negotiation, and decision-making abilities.
• High proficiency in Microsoft Office, ICT systems, and report writing.

As a member of the Aseptic Operations function, and as an Aseptic Manufacturing SME, ensures that Equipment for Aseptic Manufacturing (Equipment/ Cleanroom/ Utility) is designed according to company standards and Network Best Practice and is operating as designed. Partners with Site colleagues and other members of the Site Aseptics team, to create an environment of the highest performance standards of Aseptic Manufacturing. Drives continuous improvement in Aseptic Manufacturing Equipment on site.

Why you should apply:

• You will join an innovative team, working among a diverse group of visionaries, thinkers and doers, working on developing pioneering solutions that lead to shared success.
• They put their people first and live their diversity and inclusion values embracing all perspectives.

What you will be doing:

• Acts as the Subject matter Expert for Equipment, Cleanroom and Utility systems related to Aseptic Manufacturing
• Responsible for ensuring that Equipment, Cleanroom and Utility systems required for Aseptic Manufacturing are in compliance with relevant Safety and Environmental Regulations, Aseptic and GMP Regulatory requirements and Network Aseptic Best Practice.
• Supports existing process Engineering systems related to Aseptic Manufacturing.
• Real-Time monitoring of Cleanroom performance (e.g., temperature, Relative Humidity, Differential Pressure, Air Fow velocity etc.).
• Real-Time monitoring of Utility performance.
• Real-time monitoring of Critical Equipment cycles (e.g., CIP, SIP, VHP, Aseptic Filling, Autoclaves,
  Lyophilization, Depyrogenation, Bulk Heat Sterilization etc.).
• Monitoring, investigation and addressing of Automation alarms.
• Trending performance and developing/ executing action plans as required.
• Partners with other members of the Site Aseptics Team (e.g., Quality SMEs, Operations SMEs, Aseptic MQA and Aseptic mentors) to ensure required support is provided to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner, assuring sterility of the product.
• Participates in troubleshooting & Investigation for equipment/ cleanroom/ Utility related events.
• Actively participates and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.
• As part of the Site Aseptics Team, drives continuous improvement of Aseptic Manufacturing Engineering systems and procedures through:
  a) Continuously assessing, interpreting, and applying new Aseptic Manufacturing Regulations to Site
  Engineering systems in a timely manner.
  b) Development and implementation of Best Practices in Aseptic Manufacturing.
• Provides key input into of the design of systems.
• Ensuring an extensive knowledge of the systems.
• Ensuring an extensive knowledge of Engineering standards.
• Ensuring that any deviation from Engineering standards goes through the required approval process.
• Leading Projects related to equipment, cleanroom and utility equipment change.o Ensuring all alarms are ranked according to criticality.
• Approves Preventative Maintenance strategy for Equipment, Cleanroom and Utilities.
• Ensures that all Engineering system changes follow Site Change Control procedures.
• Ensures appropriate use of Risk Management tools to drive Aseptic performance/ Sterility Assurance
• Supports regulatory audits as Aseptic/ Sterility Assurance Engineering system subject matter expert.
  anticipates and provides leadership to the Site Aseptics team, highlighting and leading the introduction of continuous improvement initiatives.
• Drives a high-performance culture in Aseptic Manufacturing. Drives a culture of Speak-Up.
  Participates in routine leadership GEMBAs of Manufacturing and Testing areas.
  Provides key input into Site Contamination Control Strategy, APS Strategy, Aseptic Manufacturing processes.

What you need to apply:

• Third Level Degree in an Engineering or equivalent discipline.
• 3+ Years of experience in a GMP Environment with 1+ years of experience in support of Aseptic Manufacturing.
• Strong knowledge of Regulatory Requirements Project Management experience.
• Excellent communication skills.