Description:
PE Global is currently recruiting for a CQV Engineer on behalf of a leading pharmaceutical company based in Cork.
Overview:
- As part of the Technical Compliance Team, this contract position is responsible for all activities required to support project commissioning and qualification.
Responsibilities:
- Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
- Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
- Prepare C&Q protocols as required (e.g. URS’s / SRS’s, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
- Review and approve documents prepared by contractor organisations (e.g. vendor SAT’s, FAT’s, commissioning protocols, project change controls/notifications).
- Execute C&Q protocols as required.
- Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols / reports.
- Complete activities / deliverables in accordance with each project’s site change control required deliverables (from a C&Q perspective).
Education and Experience:
- Third level degree and relevant experience.
- Minimum 5+ years’ experience in the Pharmaceutical (API) Industry.
- Experience of commissioning and qualifying some of the following systems:
- Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
Contract 
CarlowIreland 
42038595 
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