Senior Process Engineer
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| Job Type | Contractor |
| Area | Waterford, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | David Connolly |
| Job Ref | 1002568 |
| Job Views | 551 |
- Description
- Senior Process Engineer
Team Horizon is seeking a Senior Process Engineer for a leading manufacturing company in Waterford city. In this role you will provide process engineering support and project leadership to support internal customers in the day to day operations of the organization and site capital projects, enabling delivery of high quality projects safely, on time and within budget.
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 Waterford.
They put their people first and live their diversity and inclusion values embracing all perspectives.
What you will be doing:
Identify and manage process improvements and projects.
Comply at all times with the Health, Safety and Environmental policy and associated procedures, legislative requirements.
Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
Ensure safety management is paramount in project delivery processes
Lead by example and take ownership of EHS matters in relation to engineering activities you are involved in.
Ensure all work carried out is in compliance with the required standards, conforming to company policy, cGMP, SOP and regulatory guidelines.
Lead by example and take ownership for quality compliance in relation to engineering activities you are involved in.
Ownership of equipment qualification and process validation from a quality compliance perspective.
Identify and manage process improvements and projects
Lead in the procurement, introduction, commissioning and qualification of process equipment and subsequent process validations
Ensure qualification methodology is clear and integrated into the project from URS onwards
Ensure documentation, training and handover meet the internal customers’ expectations
Life cycle cost considered in designs for maximum long term efficiency and reliability
Plan and execute process validation schedules for manufacturing and packaging processes.
Write and execute documents for the validation of new and existing processes.
Liaise with contractors/customers when external resources are required to complete validations.
Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure validation activities are planned and executed in line with applicable deadlines.
Assist with submission/audit/deficiency responses activities when required, in a timely manner.
Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
Generate, analyse and interpret statistical data to verify acceptable criteria has been met and support process validations, CPVs
Develop testing strategies and rationale for manufacturing and packaging process equipment qualification and process validation.
Provide technical support/troubleshooting for process and equipment issues.
Investigate/resolve deviations associated with validation activities.
Utilise structured problem solving in support of process issues & problem resolution.
Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform under your behest
Develop relationships with contractors, ensure they understand our business and are compliant to site procedures
Report covering schedule, cost control, project scope and risks / mitigations, compiled at appropriate intervals
All project and equipment related information stored centrally
Ensure clear, concise communications with internal & external stakeholders
All other duties as requested or assigned.
What you need to apply:
Be a qualified Process Engineer with a degree in an Engineering discipline.
Have 5+ years’ experience working in a clean room, Pharma, medical device or similar manufacturing and/or packaging environment.
Ideally you will have experience in process validation (including statistics training) and the management of small capital projects along with knowledge of the processes and equipment used in the manufacture and packaging of tablets and capsules.
Knowledge of cGMP, EU Annex and GAMP requirements, an understanding of integrated validation approaches and familiarity with Minitab or similar statistics software is an advantage.
