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CSV Engineer
2 weeks ago
CSV Engineer
The CSV Engineer ensures the ongoing validation compliance of computerized equipment and systems within sterile products manufacturing at Sanofi Ireland. They play a critical role in validating new equipment and supporting compliance with regulatory and company standards.
Responsibilities
Lead validation activities for computerized equipment and control systems, including generating and executing validation documentation (DQ, IQ, OQ, PQ).Manage validation projects ensuring compliance with Sanofi policies, cGMP, and regulatory requirements (US FDA, EU).Participate in change control processes and approve validation/revalidation plans and site change controls.Provide technical support related to lyophilization, aseptic processing, sterilization, and other critical manufacturing systems.Maintain validation documentation and ensure continuous compliance with quality management systems and KPIs.Requirements
Degree in Science (preferably Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical), with post-graduate qualifications a plus.3-5 years' experience in healthcare manufacturing, ideally pharmaceutical, with 2-3 years in a validation role.Strong knowledge of GAMP, ISPE Baseline guides, quality and compliance regulations, and pharmaceutical plant operations.Skilled in troubleshooting validation issues, project management, and effective communication across teams.Personal traits include being motivated, adaptable, pragmatic, a natural influencer, and able to see projects through completion.#LI-MS2
