Senior CQV Engineer – GMP Validation Expert

Syner G; United States; Hybrid; USD 120,000 - 140,000; Full time

Benefits offered by this job

Remote-friendly work options

Office locations: Greater Boston, San-

Flexible PTO

Company holidays

Job summary

Syner-G seeks a CQV Engineer with 7–11 years of experience to support commissioning, qualification and validation activities for GMP facilities, utilities, equipment and automation systems.

You'll execute IQ, OQ and PQ protocols, review documentation, manage deviations, and support regulatory inspections, collaborating with Engineering, Operations, and Quality to ensure compliant system turnover and project milestones.

Qualifications

• Strong knowledge of commissioning, qualification and validation within GMP-regulated environments.
• Experience executing IQ/OQ/PQ protocols and functional testing.
• Familiarity with deviation management, change control, and quality systems.

Responsibilities

• Review approved design, vendor, turnover, and qualification docs for CQV execution.
• Execute commissioning and qualification protocols (IQ/OQ/PQ) and verify equipment/utility performance.
• Coordinate testing with multi-disciplined teams to support schedules and releases.
• Develop qualification summary reports and turnover packages.
• Support regulatory inspections, audits, and quality initiatives related to CQV.

Skills

GMP knowledge

IQ/OQ/PQ protocols

Documentation quality

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Syner-G seeks a CQV Engineer with 7–11 years of experience to support commissioning, qualification and validation activities for GMP facilities, utilities, equipment and automation systems.

You'll execute IQ, OQ and PQ protocols, review documentation, manage deviations, and support regulatory inspections, collaborating with Engineering, Operations, and Quality to ensure compliant system turnover and project milestones.