Project Engineer

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading Life Sciences consultancy in Singapore is seeking a professional with CQV experience to contribute to Life Science projects. The candidate will be responsible for developing and executing C&Q documentation, supporting the qualification of process and utility systems, and resolving technical issues. A Bachelor's degree in a relevant engineering field and 3-7 years of industry experience are required. The role emphasizes collaboration with multiple teams and adherence to strict GMP standards.

Qualifications

• 3–7 years of CQV experience in the pharmaceutical industry.
• Strong understanding of GMP, GEP, and FDA/EMA validation expectations.
• Experience in process equipment qualification and clean utilities.

Responsibilities

• Develop and execute C&Q documentation including commissioning protocols.
• Support end-to-end C&Q lifecycle for process and utility systems.
• Troubleshoot and resolve technical issues during C&Q execution.

Skills

GMP understanding

Documentation management

Strong communication

Risk-based CQV approach

Education

Bachelor’s Degree in Chemical, Mechanical, Biomedical Engineering

Tools

Veeva

Job description

Job Description

• Contribute to Life Science projects for Antaes Asiaclients.
• Develop and execute C&Q documentation including commissioning protocols, SAT reports, IQ/OQ/PQ protocols, summary reports, and traceability matrices.
• Support end-to-end C&Q lifecycle for process, utility, and support systems — e.g. bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, and clean utilities.
• 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 SAT with suppliers and engineering teams.
• Troubleshoot and resolve technical issues encountered during C&Q execution.
• Ensure all C&Q 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 Antaesservices 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 liaison with English speaking counterparts.