CQV Engineer/Validation Engineer
Job in
Harvard, Worcester County, Massachusetts, 01451, USA
Listed on 2025-12-11
Listing for:
EPM Scientific
Full Time
position Listed on 2025-12-11
Job specializations:
-
Engineering
Validation Engineer, Biomedical Engineer, Quality Engineering
Job Description & How to Apply Below
Location: Harvard
This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range$70,000.00/yr - $/yr
Quality Assurance/Control Recruitment Consultant | Specializing in Life Sciences Talent at EPM ScientificLocation: Devens, MA
Employment Type: Full-Time, On-Site
Salary Range: $70,000-$109,000/year
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 Val Genesis and familiarity with electronic protocol management systems.
Key Responsibilities- Author, edit, and execute commissioning, qualification, and validation documentation (URS, IQ, OQ, PQ) using Val Genesis
- 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
- 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 Val Genesis (required)
- Experience setting up or implementing Val Genesis 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
- 401(k) with employer match
- Paid time off, holidays, and sick time
- Tuition reimbursement and professional development opportunities
Entry level
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