Senior CQV Engineer – Remote GMP Validation

BioSpace; San Diego (CA); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Flexible Paid Time Off

Fully remote options

Office in San Diego / Greater Boston

Job summary

Syner-G is seeking a CQV Engineer with 7–11 years of experience to lead commissioning, qualification, and validation activities for GMP-regulated facilities and systems. You will execute IQ/OQ/PQ protocols, review design and vendor documents, and support turnover to Operations and Quality with rigorous documentation.

Collaborating across Engineering, Construction, Automation, and QA, you will ensure systems are installed, tested, and released per requirements and regulatory expectations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 7–11 years in commissioning, qualification, validation in pharma/biotech.
• Strong knowledge of FDA cGMP requirements and GDP practices.
• Experience with IQ/OQ/PQ and validation protocols.
• Experience reviewing engineering docs (P&IDs, specs, drawings).

Responsibilities

• Review design, vendor, turnover docs for CQV execution.
• Support system walkdowns, field verification, readiness reviews.
• Execute IQ/OQ/PQ, functional testing and acceptable documentation.
• Coordinate testing with Engineering, Construction, Automation, Operations, QA & vendors.
• Develop qualification summaries and turnover packages.

Skills

CQV engineering

Regulatory compliance

IQ/OQ/PQ execution

Documentation management

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Electronic quality systems

GMP documentation systems

Job description

Syner-G is seeking a CQV Engineer with 7–11 years of experience to lead commissioning, qualification, and validation activities for GMP-regulated facilities and systems. You will execute IQ/OQ/PQ protocols, review design and vendor documents, and support turnover to Operations and Quality with rigorous documentation.

Collaborating across Engineering, Construction, Automation, and QA, you will ensure systems are installed, tested, and released per requirements and regulatory expectations.