Process Engineer
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 carried out 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. Co-ordinate and participate in the development of risk assessment 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 taking account of manufacturers recommendations, production drivers and GMP and GEP requirements.
8. Management of external contractors for the execution of specialist maintenance activities, including feeding back and monitoring on performance.
9. Define equipment spares requirements, identifying specifications, sources of supply and stock levels.
10. Advise on equipment selection, participating in detailed design development and working with technical services to ensure robust solutions are implemented to ensure reliability.
11. Leads or coordinates project planning, resourcing, reporting, commissioning activities for engineering projects.
Your Background:
12. HNC/HND/Degree qualified in a relevant engineering discipline (e.g., chemical, electrical, mechanical engineering).
13. EngTech / IEng or working towards professional status.
14. Project Management training – CAPM / PMQ (or equivalent).
15. Understanding / training in Lean Six Sigma.
16. Professional membership - IMechE, IET, PMI, APM, ISPE (or similar).
17. Practical experience of GMP manufacturing, packaging processes &/or equipment within MHRA / FDA regulated facilities.
18. Demonstrable awareness of commissioning, qualification, and validation project activities.
19. Comfortable with technology.