Senior CQV Engineer / Senior Validation Engineer

Devens, MA, US • Posted 22 hours ago • Updated 30 minutes ago
Contract W2
Contract Corp To Corp
Contract Independent
On-site
Fitment

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Job Details

Skills

  • Drawing
  • IDS
  • SIP
  • Documentation
  • Regulatory Compliance
  • Quality Assurance
  • Biomedical Engineering
  • Chemical Engineering
  • GMP
  • GDP
  • IQ
  • OQ
  • Mapping
  • Chromatography
  • Performance Management
  • Project Management
  • Preventive Maintenance
  • EXT
  • IMG

Summary

Senior CQV Engineer / Senior Validation Engineer

Devens, Massachusetts

3 months contract- 6/15-9/15

Senior Validation Engineer Responsibilities:

  • Execute IQ/OQ protocols and support operational verification activities
  • Perform Drawing walkdowns (P&IDs, system verification)
  • Perform Equipment/component verification
  • Perform MOC and weld verification
  • Support temperature mapping activities using data loggers and validation tools
  • Assist with SIP/CIP execution and cycle development activities
  • Identify and document deviations and support investigations
  • Ensure accurate and complete documentation in compliance with GMP/GDP standards
  • Work collaboratively with engineering, QA, and operations teams

Job Requirements:

  • Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
  • 3 8 years of CQV/validation experience
  • Hands-on experience executing validation for process equipment
  • Strong GMP/GDP fundamentals
  • Experience with IQ/OQ execution and field verification activities
  • Experience with eVal (required), ValGenesis a plus
  • Exposure to temperature mapping (Ellab a plus)
  • Experience with bioprocess equipment preferred (bioreactors, filtration, chromatography, UF)
  • This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

Ayush Sharma Sr. US Technical Recruiter

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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91022079
  • Position Id: 2026-48552
  • Posted 22 hours ago
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