Senior Validation Engineer
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 environments and enjoy hands-on work with equipment, processes, and documentation, this could be a great fit. You'll be helping make sure everything runs smoothly and meets regulatory standards.
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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