CQV Engineer
CQV Engineer
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.
Your profile
Job Requirements:
- Bachelor’s degree in chemical, mechanical, biomedical, or a related engineering field.
- 3–7 years of CQV experience in the pharmaceutical industry.
- A strong understanding of GMP, GEP, ISPE Baseline Guides, ASTM E2500, and FDA/EMA validation requirements.
- Experience in process equipment qualification (bioreactors, chromatography, UF/DF, CIP/SIP), clean utilities, and automation integration.
- Familiar with risk-based CQV approaches and change control processes.
- Proficiency with documentation management systems (e.g., Veeva).
- Candidates must be highly motivated, able to work both independently and as part of a team, and possess strong organizational and oral and written communication skills.
- Excellent communication skills, both written and verbal, in English - to coordinate and liase with English speaking counterparts.
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 15 consulting firms in Switzerland. We have more than 300 experienced engineers who share our passion.
With offices in Switzerland, Singapore, Hong Kong, and France, we support our clients and international clients by providing services in the following areas:
- Organizational and Transformation Consulting
- Industrial Engineering
- Information Systems Management
When you join our team, you’ll discover:
- A dynamic team with a startup mindset
- Personalized support and guidance as your career progresses
- Challenges to help you grow your network
- Events: team-building activities, meetups, workshops, Winter Event …
-
A company certified by @HappyAtWork with a strong commitment to CSR (Ecovadis Gold Medal 2023)
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CQV Engineer
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.
Your profile
Job Requirements:
- Bachelor’s degree in chemical, mechanical, biomedical, or a related engineering field.
- 3–7 years of CQV experience in the pharmaceutical industry.
- A strong understanding of GMP, GEP, ISPE Baseline Guides, ASTM E2500, and FDA/EMA validation requirements.
- Experience in process equipment qualification (bioreactors, chromatography, UF/DF, CIP/SIP), clean utilities, and automation integration.
- Familiar with risk-based CQV approaches and change control processes.
- Proficiency with documentation management systems (e.g., Veeva).
- Candidates must be highly motivated, able to work both independently and as part of a team, and possess strong organizational and oral and written communication skills.
- Excellent communication skills, both written and verbal, in English - to coordinate and liase with English speaking counterparts.
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting firm ranked among the top 15 consulting firms in Switzerland. We have more than 300 experienced engineers who share our passion.
With offices in Switzerland, Singapore, Hong Kong, and France, we support our clients and international clients by providing services in the following areas:
- Organizational and Transformation Consulting
- Industrial Engineering
- Information Systems Management
When you join our team, you’ll discover:
- A dynamic team with a startup mindset
- Personalized support and guidance as your career progresses
- Challenges to help you grow your network
- Events: team-building activities, meetups, workshops, Winter Event …
-
A company certified by @HappyAtWork with a strong commitment to CSR (Ecovadis Gold Medal 2023)
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