Quality Engineer

Team Horizon is seeking a Quality Engineer to join our client in Sligo. In this role you will assist the department in providing an effective facility design to service sterile biologics manufacturing ensuring sterility assurance requirements are met from design, sterile filling and aseptic principles. You will Implement the facilities sterility assurance program and microbiological support activities (facility design, filling of sterile product and aseptic practices). Reports to the QA Operations Lead.

 

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.


• 
  Any other duties as assigned 

 

What you will be doing:

• 
  Lead and implement microbiological services to meet and maintain all requirements for aseptic processing, facility design and filling of sterile product.


• 
  Overview of the EM and utilities program process, aseptic progamme and contamination control strategy in a multiproduct facility.


• 
  Provide microbiological/sterility assurance governance of in process and finish product per product requirements.


• 
  Understand Regulations and business processes required to maintain the client’s and cGMP requirements for sterile product, inclusive of facility design, cross contamination controls,  microbiological Laboratory standards and Data Integrity.


• 
  Define and update procedures for site relative to microbiological and environmental monitoring.


• 
  Interface with regulatory and corporate inspectors/auditors.


• 
  Carry out training as per training plan to support facility sterility assurance program.


• 
  Adheres to and supports all EHS & E standards, procedures and policies. 

EHS Responsibilities:

• 
  Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;


• 
  Continually be conscious of your own safety and that of others, always complying with safety notices and barriers;


• 
  Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve;


• 
  Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve;


• 
  Attend all required EHS training and medical surveillance programs;


• 
  Wear PPE as required.


• 
  Ownership/Accountability


• 
  Is responsible for the smooth and compliant running of the sterility assurance program, process improvements, laboratory based  method, process and practices.


• 
  The position has a high level of autonomy and individuals are expected to work on their own initiative.


• 
  Ensuring team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines as all times.


• 
  Demonstrates an ethos of Right First Time at all times.


• 
  Shows a high level of tenacity to ensure closure of issues.


• 
  This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned.


• 
  Influence/Leadership


• 
  Microbiology and sterility assurance SME.


• 
  Is a site SME on all Microbiological & Environmental Monitoring topics and provides guidance on same.


• 
  Contributes to the successful delivery of site CJR’s and Goals.


• 
  Leads the delivery of new Sterility Assurance/ Microbiological initiatives.


• 
  Decision Making/Impact


• 
  Every employee has a personal responsibility to commit to the client’s Vision, to engage and align with the client’s Strategic Imperatives, and to consistently execute in accordance with the client’s Operational Pillars and the client’s Ways of Work. 


• 
  Expected to handle all day to day microbiological / environmental.


• 
  Responsible for the presentation of technical data to stakeholders to ensure prompt decisions on Microbiological related issues.


• 
  Supervision Received


• 
  Operates in an environment which is largely self-managed but with supervision through the QA Operations Lead.


• 
  Individual is given authority to carry out their duties without close supervision.


• 
  Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.


• 
  Supervision Provided


• 
  Provides supervision to 1-6 direct reports as required


• 
  Is responsible for setting annual goals, completing reviews, growth plans and performance management of the team.

 

What you need to apply:

• 
  Other Bachelor Degree qualification in biology or microbiology. Masters preferable.


• 
  Technical/Business Knowledge required.


• 
  A thorough knowledge of aseptic and sterile processes together with experience within a GMP environment and knowledge of current EU/FDA/ICH/HPRA and Annex 1 guidelines.


• 
  3 -5 years’ (minimum) experience in microbiology is a requirement & working in a sterile/aseptic/pharma environment is a distinct advantage.


• 
  Experience in supporting regulatory inspections HPRA, FDA etc is an advantage.


• 
  Experience in cleaning validation is an advantage.


• 
  Cognitive Skills.


• 
  Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures and requirements.


• 
  Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.


• 
  Requires proven problem solving skills and the ability to adapt to new requirements.


• 
  Is results driven striving to meet all targets and metric standards as set by department/site and division leaders.


• 
  Prioritises their own and their teams work in line with business demands.


• 
  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.


• 
  Strong interpersonal skills are required.


• 
  Supports the principles of Perfect Performance.