CQV Engineer

3 days ago

Singapore ANTER CONSULTING PTE. LTD. Full time $80,000 - $120,000 per year
About the Role

We are hiring an experienced CQV Engineer (Clean Utilities & HVAC) to join our our team supporting our client on the execution phase of a brownfield pharmaceutical expansion in Singapore. This role will focus on hands-on execution, coordination, and closure of qualification activities to ensure readiness for operational use and regulatory inspection.

Key Responsibilities
  • Execute pre-approved CQV protocols (IQ/OQ/PQ) for:

Clean Utilities: Purified Water (PW), Water for Injection (WFI), Clean Steam, Process Air, Compressed Gases.

HVAC Systems: Cleanroom AHUs, pressure cascades, temperature/humidity control, HEPA integrity, and room qualification.
- Coordinate test execution with construction, automation, operations, and QA teams to ensure smooth system turnover.
- Perform field execution and data collection, ensuring accuracy, traceability, and compliance with GMP requirements.
- Record, investigate, and resolve deviations, non-conformances, and punch list items during execution.
- Support loop checks, functional tests, and integrated system testing as part of qualification readiness.
- Participate in system handovers from construction to CQV and CQV to operations.
- Ensure all executed documentation is reviewed, approved, and archived according to project procedures.
- Support change control and requalification activities as needed.
- Maintain a proactive safety and quality culture in all onsite work.

Qualifications & Experience
  • Degree or Diploma in Mechanical, Chemical, Electrical, or Process Engineering.
  • 3–7 years of experience in CQV execution within a GMP-regulated pharmaceutical or biotech facility.
  • Proven hands-on experience with clean utilities and HVAC system qualification.
  • Familiarity with GMP / GEP principles, ASTM E2500, and ISPE baseline practices.
  • Practical understanding of FAT/SAT, loop checks, IQ/OQ/PQ, and system lifecycle traceability.
  • Experience in brownfield or live-site environments preferred.
  • Strong coordination, communication, and documentation skills.

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