Senior CQV Engineer - GMP Validation

Energy Jobline ZR; San Diego (CA); On-site; USD 120,000 - 140,000; Full time

Job summary

Syner-G in San Diego, CA is seeking a CQV Engineer with 7–11 years of experience to lead commissioning, qualification, and validation activities for GMP-regulated facilities and processes. You will collaborate across Engineering, Construction, Automation, Operations, Quality, and vendors to ensure systems are installed, tested, and released in compliance with FDA cGMP and project timelines.

Join a dynamic team focused on delivering validated systems, supporting regulatory inspections, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 7–11 years of commissioning, qualification, validation in pharma/biotech or regulated life sciences.
• Strong understanding of FDA cGMP and GDP documentation practices.
• Experience executing IQ, OQ, PQ and validation protocols.
• Experience reviewing engineering docs, turnover packages, and vendor documentation.
• Strong communication and cross-functional collaboration abilities.

Responsibilities

• Review approved design, vendor, turnover, and qualification docs for CQV execution.
• Lead system walkdowns, field verifications, readiness assessments.
• Execute IQ, OQ, PQ protocols and document outcomes.
• Verify installation and operation of equipment, utilities, and automation against drawings and specs.
• Coordinate testing with Engineering, Construction, Automation, Operations, QA and vendors.
• Document discrepancies, deviations and support CAPA and retesting.
• Develop qualification summary reports, turnover docs, and closeout packages.

Skills

IQ/OQ/PQ testing

GMP compliance

Documentation management

Cross-functional collaboration

Regulatory inspections

Troubleshooting

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office

Electronic quality systems

Job description

Syner-G in San Diego, CA is seeking a CQV Engineer with 7–11 years of experience to lead commissioning, qualification, and validation activities for GMP-regulated facilities and processes. You will collaborate across Engineering, Construction, Automation, Operations, Quality, and vendors to ensure systems are installed, tested, and released in compliance with FDA cGMP and project timelines.

Join a dynamic team focused on delivering validated systems, supporting regulatory inspections, and