CQV Engineer: GMP Validation for Life Sciences Systems

Trinity Consultants Engineering & EHS Workforce Solutions; Arizona; On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

PTO

Holiday pay

Medical insurance

Dental coverage

Vision benefits

401K with company match

Job summary

Trinity Consultants Engineering & EHS Workforce Solutions is seeking a Commissioning, Qualification, and Validation (CQV) Engineer for a Life Sciences project-based assignment. The role covers IQ/OQ/PQ execution, validation documentation, and turnover to readiness for GMP production.

The ideal candidate will have extensive experience in design documentation, validation within FDA-regulated environments, and strong technical writing skills, able to interface with R&D, Manufacturing, and

Qualifications

• Experience in design documentation (URS / FRS / DS) and validation within FDA-regulated manufacturing.
• Experience with drug product manufacturing, including isolators, filling lines and formulation areas.
• Experience with Process Engineering or Process Validation.
• Strong written and verbal communication and technical writing skills.

Responsibilities

• Draft and implement Quality System documentation to establish good validation practices.
• Author URS, IQ, OQ and PQ protocols and execute them per GDP guidelines and internal standards.
• Design validation approaches with statistical analyses; perform and coordinate validation activities and draft reports.
• Provide input on user and functional requirements of processing equipment and interface with Contract Manufacturers.
• Support non-engineering staff to ensure technology transfer and continuous improvement.
• Execute duties on time; proactively communicate delays to validation manager and stakeholders.
• Comply with regulatory, corporate, and Quality System policies.

Skills

Validation planning

IQ/OQ/PQ protocols

Regulatory compliance

Technical writing

Cross-functional collaboration

CSV tools

Data analysis

Education

B.S./M.S. in engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Trinity Consultants Engineering & EHS Workforce Solutions is seeking a Commissioning, Qualification, and Validation (CQV) Engineer for a Life Sciences project-based assignment. The role covers IQ/OQ/PQ execution, validation documentation, and turnover to readiness for GMP production.

The ideal candidate will have extensive experience in design documentation, validation within FDA-regulated environments, and strong technical writing skills, able to interface with R&D, Manufacturing, and