Onsite CQV Validation Engineer – GMP Life Sciences

Valspec; Los Angeles (CA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Premium medical coverage

401(k) with company match

Tuition reimbursement

Unique performance incentives

ESOP ownership

Job summary

Valspec in El Segundo, CA is seeking a hands-on Validation Engineer (CQV) to lead commissioning, qualification, and validation activities for GMP manufacturing facilities. This onsite, field‑oriented role collaborates with Operations, Engineering, Quality, and Validation teams.

You will develop IQ/OQ/PQ protocols, generate validation reports, and support qualification of facility systems, HVAC, cleanrooms, and GMP utilities.

Qualifications

• 2–4 years of validation experience in pharmaceutical/biotech manufacturing environments.
• Direct experience authoring and executing IQ/OQ/PQ documentation.
• Strong understanding of cGMP documentation requirements.
• Experience scheduling qualification activities.

Responsibilities

• Execute commissioning, qualification, and validation activities for GMP facilities and manufacturing systems.
• Develop and execute IQ, OQ, and PQ protocols.
• Generate validation protocols, summary reports, deviations, and protocol exceptions.
• Support qualification of facility systems, cleanrooms, HVAC systems, and GMP utilities.
• Schedule, coordinate, and execute qualification activities with cross-functional project teams.
• Review commissioning documentation and ensure readiness for qualification testing.
• Participate in project meetings as the CQV representative.
• Maintain GMP-compliant validation documentation.
• Support startup, troubleshooting, and system turnover activities.
• Work directly in manufacturing and facility environments with significant field presence.

Skills

CQV experience

Field-based engineer

Technical writing

Onsite work

Job description

Valspec in El Segundo, CA is seeking a hands-on Validation Engineer (CQV) to lead commissioning, qualification, and validation activities for GMP manufacturing facilities. This onsite, field‑oriented role collaborates with Operations, Engineering, Quality, and Validation teams.

You will develop IQ/OQ/PQ protocols, generate validation reports, and support qualification of facility systems, HVAC, cleanrooms, and GMP utilities.