CQV Engineer

-       Contribute to Life Science projects for Antaes Asia clients

-       Act as a core reviewer for CQV documentation and processes, ensuring all qualification activities are thoroughly evaluated and approved.

-       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).

-       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.

-       At least 3 years of CQV experience in the pharmaceutical industry, with specialized expertise in VS and QC Equipment / HVAC qualification alongside Computer System Validation (CSV)experience.

-       Must possess validation experience driven by a strict Quality mindset, or otherwise have direct QA validation experience.

-       Experience with other performance qualifications such as cleaning qualification or Single-Use Material (SUM)qualification would be a strong plus point.

-       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.