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CSV Validation Engineer

Company

Katalyst Healthcares & Life Sciences

Location

Nashville, Tennessee, United States

Type

Full-time

Job Summary:

  • Responsible for supporting equipment and process validation activities within a regulated environment, ensuring compliance with GMP, FDA, and Food/Consumer industry standards.

  • The role focuses on validation lifecycle execution, risk-based approaches, and cross-functional collaboration to maintain product quality and regulatory compliance.




Roles & Responsibilities:


  • Develop, execute, and report IQ/OQ/PQ protocols.

  • Perform equipment and process validation activities (e.g., mixing, packaging).

  • Conduct risk assessments and support CAPA and revalidation activities.

  • Ensure compliance with GMP, FDA, and Food/Consumer industry regulations.

  • Collaborate cross-functionally with teams and support team leadership activities.




Education &...

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