Sr. Validation EngineerEPM Scientific • Cambridge, MA, US

Sr. Validation Engineer

EPM Scientific • Cambridge, MA, US

2 days ago

Job type

Full-time

Job description

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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Validation Engineer • Cambridge, MA, US

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