Contribute to Life Science projects for Antaes Asia clients
Develop and execute CQV documentation including commissioning protocols, FAT/SAT reports, IQ/OQ/PQ protocols, summary reports, and traceability matrices.
Support end-to-end CQV lifecycle for process, utility, and support systems - e.g. bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, and clean utilities.
Participate in design reviews (URS, FDS, P&ID walkdowns) to ensure CQV considerations are integrated during project design and construction.
Manage execution of commissioning and qualification activities in alignment with project schedules, safety standards, and GMP compliance.
Support automation qualification (DeltaV, PLC, SCADA) and ensure integration with process control systems.
Review vendor documentation and coordinate FAT and SAT with suppliers and engineering teams.
Troubleshoot and resolve technical issues encountered during CQV execution.
Ensure all CQV deliverables meet internal Quality and Validation standards, and align with site Validation Master Plan (VMP).
Support handover of qualified systems to Manufacturing and Maintenance teams, including training and documentation.
Collaborate closely with cross-functional teams including Engineering, QA Validation, Manufacturing, and Automation.
Contribute to the promotion of Antaes services on top of assistance provided to clients.
Job Requirements:
Bachelor's Degree in Chemical, Mechanical, Biomedical, or related Engineering field.
3-7 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.
Familiar with risk-based CQV approach and change control processes.
Proficiency with documentation management systems (e.g., Veeva).
Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills.
Excellent communication skills, both written and verbal, in English - to coordinate and liase with English speaking counterparts.
