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.