CQV Engineer / Validation Engineer 2
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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