Project Engineer

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

ANTAES Asia is hiring a CQV Engineer in Singapore to contribute to life science projects, develop and execute CQV documentation, and support end-to-end qualification activities for bioreactors, chromatography, and clean utilities.

You will coordinate with Engineering, QA Validation, Manufacturing, and Automation, review vendor documents, troubleshoot issues, and ensure deliverables align with GMP, ISPE guides, and the Validation Master Plan.

Qualifications

• 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, 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).
• Excellent communication skills in English, both written and spoken.

Responsibilities

• Contribute to Life Science projects for Antaes Asia clients.
• Develop and execute CQV documentation including commissioning protocols, SAT reports, IQ/OQ/PQ protocols, summary reports, and traceability matrices.
• Support end-to-end CQV lifecycle for process, utility, and support systems (bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, 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 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 with cross-functional teams including Engineering, QA Validation, Manufacturing, and Automation.
• Contribute to promotion of Antaes services on top of assistance provided to clients.

Skills

CQV experience

GMP knowledge

Vendor documentation review

Communication skills

Education

Bachelor’s Degree in Chemical Engineering

Bachelor’s Degree in Mechanical Engineering

Biomedical Engineering

Tools

Veeva

Job description

Job Description

• Contribute toLife Scienceprojects forAntaesAsiaclients.
• 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 issuesencounteredduring C&Q execution.
• Ensure all C&Q deliverables meet internal Quality and Validationstandards, andalign 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 ofAntaesservices on top ofassistanceprovided 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.
• Proficiencywith documentation management systems (e.g., Veeva)
• Candidate must be highly motivated, be able to work independently as well as in a team andhave 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.