Lead CQV Engineer — GMP Capex Projects

The International Society for Pharmaceutical Engineering, Inc.; Sonoma, Northern (CA, KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

The International Society for Pharmaceutical Engineering, Inc. is seeking a Lead CQV Engineer to drive commissioning and qualification for major CAPEX projects at a flagship GMP site in California.

You will lead CQV activities, develop strategies, and coordinate with engineering, quality, validation, and operations to ensure GMP compliance and timely project delivery. Ideal candidates bring robust CQV leadership within pharma or biotech GMP environments, with deep knowledge of IQ/OQ/PQ, FAT/SAT,

Qualifications

• Experience leading CQV activities in GMP-regulated environments.
• Knowledge of GMP, validation, cleanrooms, process equipment and utilities.
• Experience delivering CQV on large CAPEX or facility expansion projects.
• Strong stakeholder management and leadership across multidisciplinary teams.
• Structured, quality-focused approach with regulatory compliance.

Responsibilities

• 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.

Skills

CQV leadership

GMP knowledge

CAPEX projects

Stakeholder management

Project leadership

IQ/OQ/PQ

Regulatory compliance

Cross-functional teams

Education

Bachelor's in Engineering

Job description

The International Society for Pharmaceutical Engineering, Inc. is seeking a Lead CQV Engineer to drive commissioning and qualification for major CAPEX projects at a flagship GMP site in California.

You will lead CQV activities, develop strategies, and coordinate with engineering, quality, validation, and operations to ensure GMP compliance and timely project delivery. Ideal candidates bring robust CQV leadership within pharma or biotech GMP environments, with deep knowledge of IQ/OQ/PQ, FAT/SAT,