Senior CQV Engineer - GMP Validation & Commissioning Remote

Syner-G

San Diego (CA)

On-site

USD 120,000 - 140,000

Full time

3 days ago

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Job summary

Syner-G is seeking a CQV Engineer with 7–11 years of experience to support commissioning, qualification, and validation activities for GMP-regulated facilities, utilities, equipment, and automation systems. You will work with Engineering, Construction, Automation, Operations, and Quality Assurance to ensure systems are tested, documented, and released per requirements.

The role requires managing protocols, field testing, discrepancies, and turnover documentation, with a focus on regulatory

Qualifications

Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
7–11 years of commissioning, qualification, validation in regulated life sciences.
Strong FDA cGMP knowledge and risk-based CQV methodologies.

Responsibilities

Review design, vendor, turnover, and qualification documentation for CQV execution.
Support system walkdowns, field verifications, readiness assessments.
Execute IQ, OQ, PQ, tests and document outcomes.
Verify installation and operation of equipment, utilities, and controls.
Coordinate testing with multiple teams to meet schedules.
Document test evidence and manage deviations and punch lists.
Support investigations, CAPAs, retesting, and closure of issues.
Prepare qualification summary reports and turnover packages.
Assist in system release and handover to Operations and QA.