CSV Validation Engineer
- Katalyst Healthcares and Lifesciences
- Nashville, Tennessee
- Full Time
- 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 & 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.
Job ID: 518877110
Originally Posted on: 4/26/2026
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