CSV Validation Engineer

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 & 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.