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Validation Engineer (Medical Device)

Intellectt INC
Boston, MA Full Time
POSTED ON 1/10/2025
AVAILABLE BEFORE 4/3/2025

Hello

Hope you are doing well.

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at 1(732)-276-1791.

Job Description : Validation Engineer II

Location : Boston, MA - 2127

Duration : 11 Months

Role Overview :

The Validation Engineer II (Equipment Engineer) will maintain GMP facilities and equipment, troubleshoot manufacturing instruments, and ensure compliance with quality standards. The role requires collaboration with cross-functional teams, documentation of equipment activities, and execution of improvement initiatives.

Key Responsibilities :

  • Write / review SOPs and Equipment Requirements Specifications.
  • Document calibration and maintenance procedures.
  • Manage and support equipment programs (installation, service, calibration).
  • Troubleshoot and resolve equipment issues, conducting root cause analyses.
  • Execute Equipment Qualification Protocols and support CAPA investigations.
  • Ensure compliance with regulations and quality standards.
  • Communicate technical findings and collaborate on improvements.
  • Perform hands-on tasks and support On-the-Job Training.

Qualifications :

  • Bachelor's degree in Engineering or Technical field.
  • 2-4 years of experience (calibration, maintenance in regulated industries preferred).
  • Strong technical problem-solving and documentation skills.
  • Effective communicator and team collaborator.
  • Machine shop experience is a plus.
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