ProClinical are working with one of the Top 5 Global Pharmaceutical Companies in their Combination and Medical Devices arm and are seeking experts in various areas including; Packaging. Our client is seeking a Packaging expert to work on a freelance basis for a minimum of 6 months. The project is likely to last 12 months and there is even further possibility of extension beyond that. The position is based in the Basel area and will require you to be on-site for 5 days p/week.
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.
Consult on the development and/or optimisation manufacturing processes for medical devices and combination products.
- Coordinate packaging development activities with the project team members for assigned projects
- 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)
- Develop packaging concepts to support early phase development
- Conduct feasibility assessments on new technology/ packaging concepts
- Develop early and late phase packaging prototypes using rapid prototyping, machined and/or soft tooling
- Conduct design for manufacture assessments
- Conduct tolerance stack analyses
- Maintain technical drawings and models
- Contribute to risk analyses
- Develop Design Input Requirements
Skills and Requirements:
- Education (minimum/desirable): Minimum: BS/MS or equivalent
- Desirable: Advanced degree in a scientific or relevant discipline (Ph.D. or equivalent).
- Languages: Good knowledge of English (oral and written). Desirable knowledge of site language.
- Successfully demonstrated several years (3-6 years) of directly related experience as principal scientist or equivalent.
- Recognized expertise in a specific area.
- Thorough knowledge of state-of-art technology/equipment/regulation as appropriate for the role.
- Thorough understanding of packaging and medical devices development processes.
- Ability to work in and/or lead interdisciplinary and/or cross-cultural teams.
- Proven leadership skills.
- Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Will Hitchcock on +44 203 0789 554 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.