Process Performance Qualification Specialist

1 week ago


Bedford, New Hampshire, United States PCI Pharma Services Full time
Key Responsibilities
  • Develop and support detailed project plans and timelines for process validation activities.
  • Prepare validation & change control documentation, including protocols, summary reports, etc.
  • Author process qualification/validation plans and compile trace matrices.
  • Perform technical reviews of deviations and planned deviations, change controls, and data analysis.
  • Participate in client and regulatory audits.

The successful candidate will possess excellent technical writing, verbal communication, and presentation skills, as well as the ability to work independently with minimal supervision. A Bachelor's degree in Chemical Engineering, Biochemistry, Biology, or related scientific discipline is required, along with a minimum of 7-10 years of pharmaceutical industry experience.



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