Process Engineer

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CK Group are recruiting for a Process Engineer, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis.

Role:

To provide operational and project engineering support, in order to maintain reliable and compliant operation of the manufacturing and packaging equipment, within the facility at Hatfield.

To ensure that operations carried out within your area of responsibility are conducted in accordance with the requirements of the Quality System, GMP Guidelines, and Industry Standards.

Key duties will include:

1. Provide engineering technical expertise to support the operations of site in accordance with Good Manufacturing Practice (GMP) and Good Engineering Practice (GEP).
2. Optimisation of Manufacturing and Packaging plant and equipment to ensure reliability and efficiency in terms of cost and availability.
3. Deliver improvements to equipment reliability and availability, maintaining metrics and KPI to demonstrate performance.
4. Coordinate and participate in the development of risk assessments and method statements associated with specified work.
5. Undertake Change Management, Deviation Investigation, Corrective Action and Preventative Action (CAPA) activities, root cause analysis (RCA), and continuous improvement projects.
6. Participate in internal and external audits.
7. Define maintenance regimes for process equipment considering manufacturers' recommendations, production drivers, GMP, and GEP requirements.
8. Manage external contractors for the execution of specialist maintenance activities, including monitoring performance and feedback.
9. Define equipment spares requirements, including specifications, sources of supply, and stock levels.
10. Advise on equipment selection, participate in detailed design development, and collaborate with technical services to ensure robust, reliable solutions.
11. Lead or coordinate project planning, resourcing, reporting, and commissioning activities for engineering projects.

Your Background:

• HNC/HND/Degree qualified in a relevant engineering discipline (e.g., chemical, electrical, mechanical engineering).
• EngTech / IEng or working towards professional status.
• Project Management training – CAPM / PMQ (or equivalent).
• Professional membership - IMechE, IET, PMI, APM, ISPE (or similar).
• Practical experience of GMP manufacturing, packaging processes, and/or equipment within MHRA / FDA regulated facilities.
• Demonstrable awareness of commissioning, qualification, and validation project activities.