1. Ensure the adaptability of new product transfer processes
2. collaborate closely with the Technology Transfer department and the project team from the early stages of projects.
3. Provide mentorship and technical advice for daily commercial product manufacturing activities. This includes identifying root causes of problems, making process modifications, and implementing new manufacturing technologies.
4. Provide technical leadership on manufacturing processes within the Operations group.
5. Handle preparatory documents for TT activities (Engineering Batch Protocol, Product Run Protocol, Water Run Work Instructions, etc.) and related reporting, including risk analysis documents.
Requirements
6. Proven experience in supporting both internal and external change by ensuring the implementation and maintenance of innovative technologies and processes, such as Single Use System.
7. Strong problem-solving skills to resolve issues related to a product line or technical projects within technical operations.
8. Outstanding ability to act as the main point of contact and interface for technical issues between technical operations and customers.
9. Expertise in providing technical support for the management of investigations, CAPA, and support for health authority inspections.
10. Ability to lead critical technical projects related to the production of commercial sterile pharmaceutical products.
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