Sr. Validation EngineerEPM Scientific • Cambridge, Massachusetts, United States
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Sr. Validation Engineer
EPM Scientific • Cambridge, Massachusetts, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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
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 :
Please apply directly in for more information!
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Validation Engineer • Cambridge, Massachusetts, United States
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