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CSV Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
5 months ago
- GMP
- Regulatory Compliance
- CAPA
- ERP
5 months ago
- 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.
CSV Validation Engineer · Katalyst Healthcares & Life Sciences