CQV Engineer

Job Description:

- 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.