CQV Engineer / Validation Engineer jobs in United States
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EPM Scientific · 2 days ago

CQV Engineer / Validation Engineer

positionNorton, MA
timeFull-time
remoteOnsite
senioritySenior Level
money$70K/yr - $114K/yr
date5+ years exp

EPM Scientific is a leading life sciences organization seeking a CQV Engineer / Senior Validation Engineer to support commissioning, qualification, and validation activities for GMP manufacturing systems and equipment. This role involves working cross-functionally with Engineering, QA, Automation, and Operations to ensure compliance and validation across projects.

BiotechnologyRecruiting
Hiring Manager
Andrew Luippold
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Responsibilities

Develop and execute IQ, OQ, and PQ protocols for manufacturing systems and equipment
Plan and manage CQV activities for new and existing projects
Review technical documentation including URS, FS, and P&IDs
Develop and apply risk‑based validation strategies
Troubleshoot commissioning issues and maintain validated state
Support cleaning validation, thermal mapping, and requalification activities
Collaborate with cross‑functional teams to meet project and compliance requirements

Qualification

CQV experienceIQ/OQ/PQ protocol developmentGMP pharma experienceAutomation commissioningCleaning validationThermal mappingElectronic validation systemsSTEM degreeTroubleshooting skills

Required

5+ years of CQV, validation, or cleaning validation experience in GMP pharma or biotech
Strong experience with IQ/OQ/PQ protocol development and execution
Ability to interpret technical documentation and troubleshoot issues
Comfortable working full‑time onsite in Norton, MA with occasional off‑hours support

Preferred

Bachelor's degree in STEM, Biomedical or Chemical Engineering
Experience with automation commissioning, Rockwell PlantPAx
Hands‑on experience with cleaning validation and thermal mapping
Familiarity with electronic validation systems such as ValGenesis, Veeva, or Kneat

Benefits

Comprehensive benefits including medical, dental, vision, retirement plans, and PTO
Professional development opportunities
Occasional scheduling flexibility to support validation activities

Company

EPM Scientific

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EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
dateFounded in 2012
location
New York, New York, USA
people-size1001-5000 employees
web-link
https://www.epmscientific.com/

Funding

Current Stage
Late Stage

Leadership Team

S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
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