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Sr. Validation Engineer
Sr. Validation EngineerEPM Scientific • Cambridge, MA, US
Sr. Validation Engineer

Sr. Validation Engineer

EPM Scientific • Cambridge, MA, US
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Title : Senior Validation Engineer

Location : Boston, MA (on-site)

About the Role :

A growing biotech company working on regenerative medicine is looking for a Senior Validation Engineer to join their team. If you're experienced in GMP biotech environments and enjoy hands-on work with equipment, processes, and documentation, this could be a great fit.

What You'll Be Doing :

  • Handling IQ / OQ / PQ for equipment, facilities, cleaning, sterilization, and manufacturing processes.
  • Writing and executing validation protocols, project plans, and final reports.
  • Coordinating with different teams to keep projects on track.
  • Updating and creating SOPs when needed.
  • Leading technical tasks and helping hit project milestones.
  • Supporting investigations, CAPAs, and equipment release.
  • Pitching in with calibration and metrology work.
  • Mentoring junior engineers and sharing your expertise.
  • Jumping in on other quality-related tasks as needed.

Requirements :

  • Bachelor's in engineering or science with 6+ years of validation experience, or a Master's with 4+ years.
  • Solid background in GMP validation-equipment, processes, utilities, or software.
  • Experience with temperature chambers, sterilization, cleaning, and depyrogenation.
  • Familiarity with GE Kaye Validator or Ellab systems.
  • Must be authorized to work in the US without visa sponsorship

    • Please apply directly in for more information!

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