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Validation Engineer

1 week ago


Summit, New Jersey, United States Omni Inclusive Full time
About Us

Omn Inclusive is a leading company in the industry, and we are seeking a skilled Validation Engineer - GMP Environment to join our team. The ideal candidate will have strong knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.

Key Responsibilities:

  • Supports the execution of equipment qualifications and validation protocols.
  • Develops qualification protocols and associated reports while adhering to a change management process.
  • Ensures equipment, facilities and programs are maintained in compliance.

Requirements:

  • Bachelor's degree in Engineering or Science related discipline required.
  • Minimum of 5 years' experience performing/supporting activities in a GMP environment.
  • Minimum of 3 years' experience in equipment, facility or utility qualification.