EPM Scientific · 3 days ago
CQV Engineer / Validation Engineer 2
Devens, MA
Full-time
Onsite
Mid Level
$70K/yr - $109K/yr
3+ years expEPM Scientific is a leading life sciences organization seeking a CQV Engineer / Validation Engineer to support commissioning, qualification, and validation activities for manufacturing equipment, systems, and processes in a GMP-regulated environment. The role involves authoring and executing protocols, managing deviation investigations, and ensuring compliance with regulatory requirements.
BiotechnologyRecruiting
Hiring Manager
Andrew Luippold
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
Qualification
Required
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)
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
Preferred
Experience setting up or implementing ValGenesis instances
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
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
BioSpectrum Asia
2023-12-23
Company data provided by crunchbase