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Lead CQV Engineer - Pharmaceutical Manufacturing - Major CAPEX Projects

Job in Santa Clara, Santa Clara County, California, 95053, USA
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
Salary/Wage Range or Industry Benchmark: 130000 - 195000 USD Yearly USD 130000.00 195000.00 YEAR
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.
Experience
  • 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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