This is an exciting opportunity for an experienced C&Q Engineer to support commissioning and qualification activities at a leading OSD pharmaceutical site in Cork. You’ll play a key role in generating, executing, and approving qualification documentation for facility, utility, and equipment systems, as well as commissioning test documents for non-direct systems.
Key Responsibilities:
- Develop, execute, and approve qualification protocols for Direct Impact Systems (facility, utility, equipment).
- Prepare commissioning test documents for non-direct systems.
- Support clean utility tie-ins and integration into live systems (e.g. purified water, compressed air).
- Ensure all activities align with cGMP and cGDP requirements.
- Deliver high-quality technical documentation and reports.
- Collaborate with cross-functional teams to ensure project timelines are met.
Requirements:
- Degree in Engineering, Science, or related technical discipline.
- 3+ years’ experience in Commissioning & Qualification within pharma (ideally OSD).
- Strong knowledge of clean utilities, hygienic piping, instrumentation, and controls.
- Experience integrating new systems into existing/operational systems.
- Excellent technical writing and documentation skills.
- Ability to work independently with minimal supervision.
- Flexible and adaptable to shifting project demands.
- Experience with Kneat or similar validation software is a plus.
Systems Exposure:
- Dispensing equipment (downflow booth, matcom stations, PTS powder systems)
- Tumble mixers & CIP skid
For a confidential discussion and more information on the role, please contact Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108