Job Summary:
The CSV Engineer plays a vital role in ensuring the ongoing validation compliance of computerized equipment and systems within sterile products manufacturing. This position requires expertise in generating and executing validation documentation, managing validation projects, and providing technical support for lyophilization, aseptic processing, sterilization, and other critical manufacturing systems.
About this Role:
* Lead validation activities, including generating and executing validation documentation.
* Manage validation projects to ensure compliance with quality management systems and regulatory requirements.
* Provide technical support related to critical manufacturing systems.
* Maintain validation documentation and ensure continuous compliance with performance indicators.
What We're Looking For:
* Degree in Science (preferably Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical), with post-graduate qualifications an asset.
* 3-5 years' experience in healthcare manufacturing, preferably 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.