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