CQV Engineer

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Antaes Asia Pte. Ltd. seeks a CQV Engineer to contribute to Life Science projects in Singapore. You will develop CQV documentation, participate in design reviews, and drive end-to-end qualification activities for complex systems such as bioreactors, chromatography skids, and clean utilities.

The role requires 3–7 years of CQV experience in pharma, strong GMP knowledge, and proficiency with automation integration. Collaboration with QA Validation, Manufacturing, and Engineering is essential.

Qualifications

• CQV experience in the pharmaceutical industry is required.
• Strong GMP, GEP, and FDA/EMA validation understanding.
• Experience with process equipment qualification and automation integration.

Responsibilities

• Develop CQV documentation including commissioning protocols, FAT/SAT reports, IQ/OQ/PQ protocols, and summary reports.
• Support end-to-end CQV lifecycle for process, utility, and support systems (bioreactors, chromatography, CIP/SIP, WFI, HVAC, autoclaves).
• Participate in design reviews to ensure CQV considerations are integrated during project design and construction.
• Manage execution of commissioning and qualification activities aligning with schedules and safety standards.
• Support automation qualification and ensure 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 VMP.
• Support handover of qualified systems to Manufacturing and Maintenance with training and documentation.
• Collaborate with cross-functional teams (Engineering, QA Validation, Manufacturing, Automation).
• Contribute to promotion of Antaes services.

Skills

CQV experience

GMP knowledge

Project coordination

English communication

Education

Bachelor's degree in Chemical/Mechanical/Biomedical Engineering

Tools

Veeva

DeltaV

Job description

Job Description:

• 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.