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.
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