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 with ability to work cross-functionally.
Experience leading or coordinating validation teams is a plus.
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.
Benefits
Opportunity to work in a regulated industry with a focus on quality assurance.
Engagement in cross-functional projects enhances teamwork skills.
Ability to lead validation activities and teams, offering growth potential.
Develop skills in compliance with FDA and GMP regulations.
Full Job Description
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.
