Process Validation Specialist

3 days ago


Bedford, New Hampshire, United States Sagax Team Full time
Process Validation Scientist

Sagax Team is seeking a highly skilled Process Validation Scientist to support the development and execution of validation protocols, ensuring compliance with client and regulatory requirements.

Key Responsibilities:

  • Develop and review validation protocols for release to manufacturing and operations teams.
  • Collaborate with internal teams to ensure validation protocols align with regulatory requirements and client needs.
  • Review batch records and ensure proper data collection for protocol alignment with fill/finish operations.
  • Assist in report writing to meet client expectations and project deadlines.
  • Ensure timely release of batch records and data for ongoing projects.

Requirements:

  • Bachelor's degree in Biochemistry, Biology, or a relevant life science field.
  • 7-10 years of experience in process validation, with expertise in upstream and downstream processes, as well as fill/finish operations.
  • Previous experience in a Contract Development and Manufacturing Organization (CDMO) is preferred.
  • Proven ability to write protocols and perform thorough batch record reviews.
  • Strong attention to detail and experience working in a client-facing role.
  • Ability to work effectively independently and in collaboration with cross-functional teams.


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