Validation Engineer

EFOR; Foxborough (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading company in biopharmaceutical manufacturing seeks a CQV Engineer to support commissioning and qualification of critical manufacturing systems. This role involves executing C&Q protocols and collaborating with various teams to ensure readiness for GMP operations.

Benefits

Medical Insurance

Vision Insurance

401(k)

Disability Insurance

Qualifications

• 3–7 years of experience in validation and commissioning in regulated manufacturing.
• Hands-on experience with clean utilities and filling lines.

Responsibilities

• Execute C&Q protocols for equipment including filling lines and autoclaves.
• Draft and review validation documentation and perform on-floor testing.

Skills

Technical Writing

Documentation

Protocol Execution

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

DeltaV

Kneat

Wonderware

Job description

1 day ago Be among the first 25 applicants

Engineer | Senior Business Manager | @ EFOR

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

Ready to shape the future of life sciences with us? Apply now and join the EFOR adventure.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting, Engineering, and Project Management

• Industries

  Business Consulting and Services, Biotechnology Research, and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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Senior Validation Specialist- Computer System Validation

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