CQV Engineer – Life Sciences Validation Expert

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 90,000 - 135,000; Full time

Job summary

ANTAES ASIA PTE. LTD. in Singapore is seeking a CQV specialist to contribute to Life Science projects and act as a core reviewer for CQV documentation and processes.

You will develop and execute CQV documentation including commissioning protocols, FAT/SAT, IQ/OQ/PQ, summary reports, and traceability matrices, and support the full CQV lifecycle across process equipment and clean utilities, ensuring GMP and QA alignment with the Validation Master Plan.

Qualifications

• 3+ years of CQV experience in pharmaceutical industry.
• Validation experience driven by a strong quality mindset or direct QA validation experience.
• Knowledge of GMP, GEP, ISPE Baseline Guides, ASTM E2500, FDA/EMA validation expectations.

Responsibilities

• Contribute to Life Science projects for Antaes Asia clients.
• Act as core reviewer for CQV documentation and processes.
• Develop and execute CQV documentation including commissioning protocols, FAT/SAT, IQ/OQ/PQ, summary reports, and traceability matrices.
• Support end-to-end CQV lifecycle for process, utility, and support systems (bioreactors, chromatography, CIP/SIP, WFI, HVAC, autoclaves).
• Participate in design reviews (URS, FDS, P&ID walkdowns) to integrate CQV during design and construction.
• Manage execution of commissioning and qualification activities per project schedules and GMP standards.
• Support automation qualification (DeltaV, PLC, SCADA) and integration with process control systems.
• Review vendor documentation and coordinate FAT/SAT with suppliers and engineering teams.
• Troubleshoot and resolve technical issues during CQV execution.
• Ensure CQV deliverables meet Quality and Validation standards and align with site VMP.
• Promote Antaes services to clients.

Skills

CQV experience

Quality mindset

Team collaboration

English communication

Education

Bachelor's in Chemical/Mechanical/Biomedical Engineering

Tools

Veeva

Job description

ANTAES ASIA PTE. LTD. in Singapore is seeking a CQV specialist to contribute to Life Science projects and act as a core reviewer for CQV documentation and processes.

You will develop and execute CQV documentation including commissioning protocols, FAT/SAT, IQ/OQ/PQ, summary reports, and traceability matrices, and support the full CQV lifecycle across process equipment and clean utilities, ensuring GMP and QA alignment with the Validation Master Plan.