Senior CQV Engineer (GMP Validation) - Remote

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

Benefits offered by this job

Flexible PTO

Remote work options

Company holidays

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 and manufacturing processes in San Diego, CA. You will lead IQ/OQ/PQ execution, document results, and collaborate with Engineering, Operations, QA, and vendors to ensure compliant system turn-overs.

The role emphasizes strong cGMP knowledge, risk-based methodologies, and meticulous documentation, with opportunities to contribute to

Qualifications

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

Responsibilities

• Review approved design, vendor, turnover, and qualification documentation for CQV execution.
• Execute IQ, OQ, PQ and functional testing protocols.
• Coordinate testing with Engineering, Construction, Automation, Operations, QA and vendors to support schedules.
• Verify installation of equipment, utilities, instrumentation, controls, and automation systems.
• Identify, document, and track discrepancies, punch-list items, and deviations encountered during execution.
• Develop qualification summary reports and turnover documentation.

Skills

CQV experience

GMP regulatory knowledge

IQ/OQ/PQ protocols

Cross-functional collaboration

Documentation discipline

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Microsoft Office

Electronic quality systems

Job description

Syner-G is seeking a CQV Engineer with 7–11 years of experience to support commissioning, qualification, and validation activities for GMP-regulated facilities and manufacturing processes in San Diego, CA. You will lead IQ/OQ/PQ execution, document results, and collaborate with Engineering, Operations, QA, and vendors to ensure compliant system turn-overs.

The role emphasizes strong cGMP knowledge, risk-based methodologies, and meticulous documentation, with opportunities to contribute to