CQV Engineer - Decommissioning
Duties / Deliverables / Measurable’s for the role:
- Generation of list of C&Q tests (Installation Verification (IV)/Installation Qualification (IQ), Operational Verification (OV), Operational Qualification (OQ), Performance Testing (PT) and Performance Qualification (PQ).
- Generation of validation documentation during the decommissioning process.
- Execution of process commissioning & qualification tests in adherence with decommissioning project schedule.
- Retains sole ownership and responsibility for commissioning and qualification documents from generation, through pre-approval, execution, post-execution review and final sign-off.
- Supporting validation activities and CIP/Cleaning verification during the handover of the decommissioned shell.
- Degree or HNC/D qualified in an Engineering based subject or related experience in an Equipment/Commissioning/Validation role
- Experience with decommissioning of a pharmaceutical facility desirable
- Experience within Pharma/ Primary manufacturing environment responsible for commissioning, qualification of equipment
- Familiarity with unit operations involved in the manufacture of primary products.
- Compilation and development of associated Commissioning, Qualification and Validation documentation in line with GMP standards
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