Lead CQV Engineer - Pharmaceutical Manufacturing - Major CAPEX Projects
Job in
Santa Clara, Santa Clara County, California, 95053, USA
Listed on 2026-08-12
Listing for:
The International Society for Pharmaceutical Engineering, Inc.
Full Time
position Listed on 2026-08-12
Job specializations:
-
Engineering
Pharma Engineer, Validation Engineer, Quality Engineering -
Pharmaceutical
Pharma Engineer, Validation Engineer, Pharmaceutical Manufacturing, Quality Engineering
Job Description & How to Apply Below
Lead CQV Engineer
- Pharmaceutical Manufacturing
- Major CAPEX Projects
A global pharmaceutical manufacturer is looking for an experienced Lead CQV Engineer to play a key role in the delivery of major capital investment projects across a flagship GMP manufacturing site.
Working as part of a high-performing engineering team, you'll lead all CQV activities, ensuring new facilities, utilities, equipment and processes are successfully brought into GMP-compliant operation.
What you'll be doing- Lead the full CQV lifecycle across major pharmaceutical CAPEX projects.
- Develop and execute Commissioning & Qualification strategies, plans and protocols.
- Manage FAT, SAT, IQ, OQ and support PQ activities for manufacturing equipment, clean utilities and facilities.
- Coordinate with Engineering, Quality, Validation, Operations and project teams to ensure successful project delivery.
- Ensure all commissioning and qualification activities comply with GMP, FDA and global regulatory requirements.
- Support project schedules, technical issue resolution, risk management and operational handover.
- Proven experience leading CQV activities within pharmaceutical, biotech or other GMP-regulated manufacturing environments.
- Strong knowledge of GMP, validation, clean rooms, process equipment and utilities.
- Experience delivering CQV on large CAPEX or facility expansion projects.
- Excellent stakeholder management and leadership skills with the ability to coordinate multidisciplinary teams.
- A structured, quality-focused approach with a strong understanding of regulatory compliance.
This is an excellent opportunity to join a global pharmaceutical organisation at the forefront of major manufacturing investment, where you'll play a key role in delivering cutting-edge GMP facilities and shaping the successful completion of high-value CAPEX programmes.
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