Biotech - Cork
C&Q Engineer
12 month contract
On site - Cork
As part of the Technical Compliance Team, this contract position is responsible for all activities required to support project commissioning and qualification.
The role of the C&Q Engineer and associated activities include, the preparation and execution of commissioning and qualification protocols for site systems / equipment such as Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / grey utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
The ideal candidate would have 5+ years experience in API industry including several years working in Commissioning and Qualification of equipment
Job Responsibilities:
1. Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
2. Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
3. Prepare C&Q protocols as required (e.g. URS?s / SRS?s, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
4. Review and approve documents prepared by contractor organisations (e.g. vendor SATs, FATs, commissioning protocols, project change controls/notifications).
5. Execute C&Q protocols as required.
6. Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols / reports.
7. Complete activities / deliverables in accordance with each projects site change control required deliverables (from a C&Q perspective).
8. Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
9. Prioritize C&Q activities in line with site and project schedules.
10. Co-ordinate C&Q activities with project engineering, construction and site operations activities.
11. Co-ordinate C&Q activities with contractors and vendors as required.
12. Co-ordinate C&Q document reviews and approvals.
13. C&Q System / Equipment / Components as per site procedures.
14. Strong collaboration with Quality Department.
Experience
15. Minimum 5+ years experience in the Pharmaceutical (API) Industry.
16. Experience of commissioning and qualifying some of the following systems:
17. Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / grey utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
18. Experience preparing and executing commissioning and qualification protocols and reports.
19. Knowledge and experience of Project Delivery Processes (PDP).
20. Knowledge and experience of current Good Engineering Practices (GEP).
Following would be an advantage,
21. Experience with use of ABB Industrial IT control systems.
22. Experience of Pharmaceutical facility local and controlling instrumentation
23. Extensive experience of commissioning and qualification of production systems, utilities and facilities and change management.
24. Experience of working within a Technical Compliance / Project team in a multinational corporate environment
25. Experience of ASTM 2500 and/or Risk Based Qualification approach.
Apply today or get in touch with Angela McCauley at Life Science recruitment for more info on this and similar roles.