Validation Engineer
Description:
Job Title: CQV Engineer
Location: Foxborough Area, MA (On-site)
Industry: Biopharmaceutical Manufacturing
Contract Type: Full-time / Contract
About the Role
EFOR is seeking a CQV Validation Engineer to support commissioning and qualification of critical manufacturing systems and equipment at a state-of-the-art drug product facility. The role is focused on execution and documentation of C&Q activities across clean utilities, process equipment, and packaging/visual inspection systems within a regulated (GMP) environment.
You’ll collaborate with Engineering, Quality, MS&T, and Automation teams to ensure readiness for GMP manufacturing operations.
Key Responsibilities
Execute C&Q protocols (FAT, SAT, IOQ, PQ) for a wide range of equipment, including:
Filling Lines, Isolators, SCADA Systems
Clean Steam, WFI, and Process Air
Autoclaves, Washers, Visual Inspection Lines
Packaging equipment, including labelers, cartoners, and cobots
Conduct cycle development for sterilization equipment and support PQ runs
Draft and review validation documentation (URS, RTM, RA, DQ, IOQ protocols, summary reports)
Perform on-floor testing, sampling, and deviation documentation following cGMP and cGDP
Leverage vendor protocols and commissioning data where applicable, ensuring traceability
Collaborate closely with QA, Engineering, and MS&T to ensure timely system release
Participate in Turnover Package (TOP) preparation, data review, and closure
Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or equivalent
3–7 years of experience in validation and commissioning in regulated manufacturing
Hands-on experience with clean utilities, filling lines, or automation platforms
Familiarity with GAMP 5, ASTM E2500, and FDA/EU validation expectations
Strong technical writing, documentation, and protocol execution skills
Preferred Qualifications
Knowledge of DeltaV, Kneat, or Wonderware SCADA systems
Experience with automated inspection, isolators, or labeling/serialization lines
Familiarity with 21 CFR Part 11 and data integrity best practices
Previous involvement in startup or retrofit capital projects
Experience grouping similar equipment under family-based validation protocols
Why EFOR?
Global reach, local presence — Active in over 16 countries with dedicated teams across the U.S. and Europe
Top-tier clients — Work on strategic, cutting-edge projects in biotech, pharma, and medtech
Growth mindset — Continuous learning, mentoring, and mobility opportunities
Culture of excellence — We value innovation, transparency, and technical rigor