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CSV Validation Engineer

Job in Nashville, Davidson County, Tennessee, 37201, USA
Listing for: Katalyst Healthcares & Life Sciences
Full Time position
Listed on 2026-07-01
Job specializations:
  • Engineering
    Regulatory Compliance Specialist, Quality Engineering
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below

Job Title

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 And 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 And Experience
  • Bachelor's degree in engineering, Manufacturing, Life Sciences, or related field.
  • 3–7 years of experience in a regulated quality or validation environment.
  • Strong hands-on experience with IQ/OQ/PQ and risk-based validation methodologies.
  • Solid understanding of FDA, GMP, and Food/Consumer industry regulations.
  • Familiarity with MES and ERP systems (an asset).
  • Excellent communication skills and ability to work cross-functionally.
  • Experience leading or coordinating validation teams is a plus.
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