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Aseptic Fill Line Validation Specialist

2 months ago

Lansing, Michigan, United States Katalyst Healthcares and Life Sciences Full time
Position Overview:

We are seeking a skilled Cleaning Validation Engineer to join our team at Katalyst Healthcares and Life Sciences. This role is crucial in ensuring the integrity and compliance of our aseptic fill line operations.

Key Responsibilities:
  • Possess a minimum of 4 years of expertise in the commissioning of Aseptic Fill Line Parts Washer, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Independently manage and execute tasks with minimal supervision.
  • Design and implement protocols for Commissioning, IQ, OQ, and PQ.
  • Identify and address deviations, preparing comprehensive validation reports.
  • Exhibit strong communication abilities and familiarity with VEEV.

This position offers an opportunity to contribute to the quality assurance processes within a dynamic healthcare environment.