CQV Engineer: GMP Validation & Commissioning Lead

Trinity Consultants Engineering & EHS Workforce Solutions; El Segundo (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Trinity Consultants Engineering & EHS Workforce Solutions is seeking a Commissioning, Qualification, and Validation (CQV) Engineer for a one-year, project-based assignment in our Life Sciences/Built Pillar.

The role ensures equipment, utilities, facilities, and computerized systems are designed, installed, tested and qualified to meet GMP and regulatory requirements, covering IQ/OQ/PQ through validation documentation and turnover.

Qualifications

• B.S. or M.S. in engineering or related field.
• 8+ years in a medical device or FDA-regulated environment.

Responsibilities

• Draft and implement GMP validation documents and Quality System records.
• Author URS, IQ, OQ, PQ protocols and execute them.
• Coordinate validation activities, analyze data, and draft reports.
• Interface with equipment vendors/Contract Manufacturers on validation.
• Support technology transfer and process improvements.

Skills

Design Documentation

Process Validation

CSV lifecycle

Technical writing

Communication

Independent worker

Validation tools

ASTM E2500

Education

B.S./M.S. in engineering

Tools

Validation software

Data loggers

Test equipment

Job description

Trinity Consultants Engineering & EHS Workforce Solutions is seeking a Commissioning, Qualification, and Validation (CQV) Engineer for a one-year, project-based assignment in our Life Sciences/Built Pillar.

The role ensures equipment, utilities, facilities, and computerized systems are designed, installed, tested and qualified to meet GMP and regulatory requirements, covering IQ/OQ/PQ through validation documentation and turnover.