Project Engineer

Job Description

• Contribute to Life Science projects for Antaes Asia clients.
• 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 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.