CQV Engineer / Senior Validation Engineer

Location: Norton, MA
Employment Type: Full-Time, On-Site
Industry: Biotech / Pharma
Salary Range: $70,491 - $113,521 USD (based on experience)

Role Overview

A leading life sciences organization is seeking a CQV Engineer / Senior Validation Engineer to support commissioning, qualification, and validation activities for GMP manufacturing systems and equipment. This role works cross‑functionally with Engineering, QA, Automation, and Operations to ensure a compliant, validated state across CapEx and OpEx projects.

Key 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

Qualifications

Bachelor's degree in STEM, Biomedical or Chemical Engineering preferred
5+ years of CQV, validation, or cleaning validation experience in GMP pharma or biotech
Strong experience with IQ/OQ/PQ protocol development and execution
Experience with automation commissioning, Rockwell PlantPAx preferred
Hands‑on experience with cleaning validation and thermal mapping
Familiarity with electronic validation systems such as ValGenesis, Veeva, or Kneat
Ability to interpret technical documentation and troubleshoot issues
Comfortable working full‑time onsite in Norton, MA with occasional off‑hours support

Compensation & Benefits

Base salary range of $70,491 - $113,521
Comprehensive benefits including medical, dental, vision, retirement plans, and PTO
Professional development opportunities
Occasional scheduling flexibility to support validation activities

EPM Scientific

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