OrganOx Process Engineer, Validation Position (Halifax)

Support product validation at OrganOx in Oxford as a Process Engineer. Facilitate new product validations while collaborating with cross-functional teams. As a Process Engineer, Validation at OrganOx, you will be responsible for leading validation initiatives essential to the introduction of new medical products. Working alongside Quality, Regulatory, and Manufacturing teams, you will ensure that all processes and documentation comply with the necessary regulatory requirements. This role may allow for occasional travel and remote work opportunities, aiding in a flexible work-life balance. Key Responsibilities: - Develop and execute validation strategies for processes - Author and review documentation for validation activities - Coordinate validation efforts at various manufacturing sites - Conduct FMEA and support mitigation planning - Ensure compliance with GMP and ISO standards Requirements: - Proven experience in validation engineering in medical device industry - Solid grasp of regulatory standards and validation principles - Skilled in technical documentation writing - Experience with risk management and assessment tools - Excellent communication and project management abilities Leverage your validation expertise at OrganOx to support innovative medical solutions that enhance transplant outcomes. Apply on Kit Job: kitjob.ca/job/2pban5