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Process Validation Engineer

Katalyst HealthCares & Life Sciences
Grand Rapids, MI
Full-time

Responsibilities & Requirements :

  • yrs of experience in Manufacturing PPQ Support.
  • Working with internal GRAM staff as well as our clients do determine PPQ approach and protocol details.
  • Attending client project meetings. Writing PPQ protocols and reports.
  • Providing on the floor execution, oversight, and support to ensure that protocol challenges are executed, and samples are taken per protocol.
  • Flexibility to provide execution coverage on various shifts on weekends.
  • Delivery, storage, and management PPQ Samples on site as well as coordination of sample shipping.
  • Working with internal GRAM staff as well as our clients to resolve protocol deviations and other issues that are relevant to PPQ.
  • Peer review of protocols, reports and validation binders.
  • 30+ days ago
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