CQV Engineer

CQV Engineer
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CQV Engineer

Asia - Singapore
Industrial Engineering and Life-Science
Permanent
January 14, 2026
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About the role

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.
  • End-to-end support for the 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, SDS, P&ID walkdowns) to ensure CQV considerations are integrated during project design and construction.
  • Manage the execution of commissioning and qualification activities in line 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 the site Validation Master Plan (VMP).
  • Support the 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 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.
  • End-to-end support for the 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, SDS, P&ID walkdowns) to ensure CQV considerations are integrated during project design and construction.
  • Manage the execution of commissioning and qualification activities in line 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 the site Validation Master Plan (VMP).
  • Support the 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

Your profile

This is some text inside of a div block.

Job Requirements

  • Bachelor's Degree in Chemical, Mechanical, Biomedical, or related Engineering field.
  • 3–7 years of quality, safety, and environment (QSE) 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 communicate and work with English-speaking counterparts

About Antaes

Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.

 

With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:

  • Organization and transformation consulting
  • Industrial Engineering
  • Information Systems Management

 

By joining our teams you will discover :

  • A dynamic team in a start-up spirit
  • Human support and career development monitoring
  • Challenges to help develop your network
  • Events: team building, meet-up, workshop, Winter Event ...
  • An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)

APPLY
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CQV Engineer

Asia - Singapore
Industrial Engineering and Life-Science
Permanent

About the role

This is some text inside of a div block.

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.
  • End-to-end support for the 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, SDS, P&ID walkdowns) to ensure CQV considerations are integrated during project design and construction.
  • Manage the execution of commissioning and qualification activities in line 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 the site Validation Master Plan (VMP).
  • Support the 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

Your profile

This is some text inside of a div block.

Job Requirements

  • Bachelor's Degree in Chemical, Mechanical, Biomedical, or related Engineering field.
  • 3–7 years of quality, safety, and environment (QSE) 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 communicate and work with English-speaking counterparts
Our positions are open to people who have been recognized as disabled workers. T&S Group promotes diversity and equality in the workplace. All qualified M/F candidates are considered for employment on an equal basis.

About Antaes

Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.

 

With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:

  • Organization and transformation consulting
  • Industrial Engineering
  • Information Systems Management

 

By joining our teams you will discover :

  • A dynamic team in a start-up spirit
  • Human support and career development monitoring
  • Challenges to help develop your network
  • Events: team building, meet-up, workshop, Winter Event ...
  • An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)