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Packaging Technology Leader wanted for our client in Basel.
We are looking for an experienced packaging technology expert who can lead and manage technical activities and apply expertise to address complex design, development,operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products, processes and procedures.
Compile Design Control documentation and contributing to a high quality Design History File (DHF). Author and Review of DHF relevant documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects. You will consult on the development and/or optimization manufacturing processes for medical devices and combination products.
Ideally, we are looking for a candidate with an advanced degree material engineering or equivalent, with at least 5 years of professional experience in coordinating packaging development activities with the project team members for assigned projects.
Packaging Technology Activities:
1. Coordinate packaging development activities with the project team members for assigned projects
2. Maintain knowledge in the areas of materials (glass, polymers, rubbers, silicone/lubricants, sterile barrier systems, adhesives). Manufacturing (injection moulding, glass converting, rubber moulding, assembly, fill&finish, transport validation)
3. Develop packaging concepts to support early phase development
4. Conduct feasibility assessments on new technology/packaging concepts
5. Develop early and late phase packaging prototypes using rapid prototyping, machined and/or soft tooling
6. Conduct design for manufacture assessments
7. Conduct tolerance stack analyses
8. Maintain technical drawings and models
9. Contribute to risk analyses
10. Develop Design Input Requirements
Requirements and desired experience:
* Successfully demonstrated expertise in packaging development
* Good general understanding of physics and mechanical/material engineering as well as interaction between drugs and their primary packaging and secondary packaging.
* Good understanding of processes and regulations for development of medical devices and drug/device combination products
* Good understanding of ISO Standarts 11608
* Considerable experience in collaboration with external partners
* Good communication and technical writing skills
* Fluent in English language (spoken and written)
Duration: 24 MM++
Location: Basel, Switzerland
Does that sound interesting? Then take the next step and send us your CV as a Word Document and a daytime contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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