Senior CQV Engineer - GMP Validation & Commissioning

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

Benefits offered by this job

Annual incentive plan

Flexible paid time off

Remote work options

Office locations in multiple cities

Job summary

Syner-G in San Diego, CA is seeking a CQV Engineer with 7-11 years of commissioning, qualification and validation experience in GMP-regulated environments. You will drive IQ/OQ/PQ testing, lead cross-functional teams, and ensure systems meet design and regulatory requirements.

You will review design and vendor docs, coordinate field testing, manage deviations, and prepare turnover packages for handover to operations and quality.

Qualifications

• 7-11 years of commissioning, qualification and validation experience in pharma/biotech or other regulated life sciences.
• Strong understanding of FDA cGMP requirements and risk-based commissioning methodologies.
• Experience executing IQ/OQ/PQ and related startup/functional testing protocols.
• Ability to review engineering docs (P&IDs, specs, turnover packages) and support deviation tracking.

Responsibilities

• Lead CQV activities for commissioning, qualification, and validation across facilities and systems.
• Execute IQ/OQ/PQ protocols and document test results with objective evidence.
• Coordinate testing with Engineering, Construction, Automation, Operations, QA, and vendors to meet schedules.
• Identify, document, track, and close deviations and discrepancies during execution.
• Develop qualification summary reports, turnover docs, and system closeout packages.

Skills

CQV engineering

GMP knowledge

Documentation accuracy

Verbal and written communication

Project coordination

Problem solving

Independent contributor

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

Microsoft Office

Electronic quality systems (eQMS)

Job description

Syner-G in San Diego, CA is seeking a CQV Engineer with 7-11 years of commissioning, qualification and validation experience in GMP-regulated environments. You will drive IQ/OQ/PQ testing, lead cross-functional teams, and ensure systems meet design and regulatory requirements.

You will review design and vendor docs, coordinate field testing, manage deviations, and prepare turnover packages for handover to operations and quality.