CQV Engineer

12 hours ago

Singapore ANTER CONSULTING PTE. LTD. Full time

About the Role We are hiring an experienced CQV Engineer (Clean Utilities & HVAC) to join 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 and HVAC systems. Qualified areas include: Clean Utilities (Purified Water, Water for Injection, Clean Steam, Process Air, Compressed Gases) and 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 GMP compliance. 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. #J-18808-Ljbffr

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