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CQV Engineer / Validation Engineer 2 (Devens)
CQV Engineer / Validation Engineer 2 (Devens)EPM Scientific • Devens, MA, US
CQV Engineer / Validation Engineer 2 (Devens)

CQV Engineer / Validation Engineer 2 (Devens)

EPM Scientific • Devens, MA, US
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CQV Engineer / Validation Engineer 2

Location : Devens, MA

Employment Type : Full-Time, On-Site

Salary Range : $70,000-$109,000 / year

Position Summary

A leading life sciences organization is seeking a CQV Engineer / Validation Engineer to support commissioning, qualification, and validation activities for manufacturing equipment, systems, and processes in a GMP-regulated environment. This role requires strong experience authoring and executing protocols in ValGenesis and familiarity with electronic protocol management systems.

Key Responsibilities

  • Author, edit, and execute commissioning, qualification, and validation documentation (URS, IQ, OQ, PQ) using ValGenesis
  • Manage deviation investigations and root cause analysis; support CAPA resolution
  • Support change management activities, including impact assessments and regression analysis
  • Execute test scripts and document results; maintain clear, detailed records
  • Collaborate with cross-functional teams to meet project timelines
  • Ensure compliance with GxP and 21 CFR Part 11 requirements

Qualifications

  • Bachelor's degree in STEM (Engineering, Life Sciences preferred)
  • 3+ years of industry experience in CQV or validation
  • Strong experience authoring and executing protocols in ValGenesis (required)
  • Experience setting up or implementing ValGenesis instances (preferred)
  • Familiarity with validation lifecycle documentation and electronic protocol systems
  • Strong problem-solving and technical writing skills
  • Ability to work full-time onsite in Devens, MA

    • Salary & Benefits

  • Competitive pay plus performance-based incentives
  • Comprehensive benefits : medical, dental, vision, life insurance, disability coverage
  • 401(k) with employer match
  • Paid time off, holidays, and sick time
  • Tuition reimbursement and professional development opportunities
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