Our client is looking for experienced a C&Q engineer to support New Product Introduction in their biologics facility in Athlone.
- C&Q Engineer will be responsible for Installation and Operational tests execution, protocol generation and results reporting on process equipment and utilities systems.
Qualifications & Experience:
- Degree qualification required in a relevant discipline.
- 5 years’ experience required in a GMP environment ideally within biologics.
- Understanding of the ASTM E2500 Qualification Requirements.
- Understanding of the system/equipment qualification lifecycle: URS to Operational phase.
- Direct Experience with hands on execution of System/equipment Mechanical Completion, Installation Verification and Functional.
- Understanding of the Quality Risk Management within qualification requirements.
- Understanding of manufacturing equipment used in Biologics and Drug Product Processes.
- Understanding of the Utilities Systems and systems and their CQAs (Clean Steam, WFI, HVAC, process gasses).
- Understanding of the Aseptic and Biologics Manufacturing processes and contamination control.
- Understanding of the BMS systems and Automation architecture.
- Understanding of the ASME BPE – Bioprocessing Equipment Requirements.
- Understanding of the Quality System Elements: deviation, CAPA, calibration, preventative maintenance and change control.
To apply for this job email your details to firstname.lastname@example.org.