CQV Engineer: Life Science Validation Specialist

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

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.