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Integrity Partners Pte. Ltd. is seeking a CQV Engineer to lead qualification and validation activities in pharmaceutical environments in Singapore. The role focuses on IQ/OQ/PQ documentation, risk assessments, and ensuring GMP compliance.
The successful candidate will collaborate with engineering, project, and quality teams, validate clean utilities and equipment, and support commissioning activities to ensure operational readiness.
My client is looking out for a CQV Engineer that has the following attributes:
CQV Protocol Execution: Plan, execute, and document CQV activities (IQ, OQ, PQ) for pharmaceutical manufacturing facilities, utilities, and process equipment.
Compliance & Standards: Ensure all documentation and activities strictly adhere to GMP, GAMP 5, ISPE Baseline Guides, and FDA/EMA/PIC/S guidelines.
Testing & Troubleshooting: Support FAT, SAT, risk assessments, and technical troubleshooting during equipment setup and operational readiness stages.
Cross-Functional Collaboration: Partner with engineering, project, and quality teams to drive execution and resolve validation issues on time.
Degree in Engineering, Life Sciences, or a related discipline.
2–5 years of CQV experience within the pharmaceutical or biotech manufacturing sector.
Practical knowledge of cGMP, GAMP 5, and validation lifecycle protocols.
Hands-on experience validating clean utilities (WFI, clean steam, HVAC), cleanrooms, or process equipment.