CQV Engineer / Validation Engineer 2EPM Scientific • Devens, MA, US
CQV Engineer / Validation Engineer 2
EPM Scientific • Devens, MA, US
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 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
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
Salary & Benefits
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Validation Engineer • Devens, MA, US
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