CQV Engineer – Life Science Projects
Antaes · Singapore
Job description
About the role
Antaes, a Swiss consulting firm founded in 2007 with more than 300 engineers, is hiring a CQV Engineer in Singapore to contribute to Life Science projects for its Asia clients. The role covers commissioning and qualification of process, utility and support systems such as bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC and clean utilities, in line with GMP and the site Validation Master Plan.
Key responsibilities
- Develop and execute CQV documentation: commissioning protocols, FAT/SAT reports, IQ/OQ/PQ protocols, summary reports and traceability matrices.
- Support the full CQV lifecycle for process, utility and support systems.
- Take part in design reviews (URS, FDS, P&ID walkdowns) so CQV considerations are built into design and construction.
- Manage commissioning and qualification activities according to project schedules, safety standards and GMP compliance.
- Support automation qualification (DeltaV, PLC, SCADA) and its integration with process control systems.
- Review vendor documentation and coordinate FAT and SAT with suppliers and engineering teams.
- Troubleshoot technical issues during CQV execution and ensure deliverables meet internal quality and validation standards.
- Support handover of qualified systems to Manufacturing and Maintenance, including training and documentation.
- Collaborate with Engineering, QA Validation, Manufacturing and Automation teams.
Required profile
- Bachelor's degree in Chemical, Mechanical, Biomedical or a related engineering field.
- 3 to 7 years of CQV experience in the pharmaceutical industry.
- Strong understanding of GMP, GEP, ISPE Baseline Guides, ASTM E2500 and FDA/EMA validation expectations.
- Experience in process equipment qualification (bioreactors, chromatography, UF/DF, CIP/SIP), clean utilities and automation integration.
- Familiarity with risk-based CQV and change control processes.
- Excellent written and spoken English to liaise with English-speaking counterparts.
Required skills
- Proficiency with documentation management systems such as Veeva.
- Good organisational, oral and written communication skills, able to work independently and in a team.
Antaes describes itself as a dynamic, start-up-style team with career support, team events and a certified HappyAtWork company.
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Published 2 days ago
Expires 1 month from now
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Antaes
Singapore