Hologic

Process Validation Strategy Development

Led process validation strategy for filling and lyophilization operations at Hologic, reducing revalidation by 80% through risk-based planning and execution oversight.
HOW WE HELPED
  • Acted as the Principal Quality Engineer, leading the development of validation strategies for filling and lyophilization processes.
  • Defined sampling plans, testing methodologies, and robust validation criteria in collaboration with the engineering team to ensure alignment with regulatory and quality expectations.
  • Authored comprehensive validation protocols and provided hands-on support during protocol execution alongside engineering teams.
  • Conducted thorough reviews of validation results and ensured the timely approval of validation reports.
  • Achieved an 80% reduction in revalidation needs by establishing clear, risk-based validation criteria upfront, and minimizing process deviations.

    • Revalidation Reduction

    80%

    Process Types Covered

    Filling & Lyophilization

    Role

    Principal QE

    Validation Support

    End-to-end
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