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!