Biology, Communication Skills, Consumer Regulations, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, ERP (Enterprise Resource Planning), Equipment Validation, FDA (Food and Drug Administration), Food and Beverage Industry, GMP (Good Manufacturing Practices), Industry Standards, Leadership, Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), Process Validation, Quality Management, Regulatory Compliance, Risk, Risk Analysis, Team Lead/Manager
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.
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Katalyst Healthcares & Life Sciences