128 days ago on sjobs.brassring.com

Technical Expert - Medical Devices

Novartis Pharma Schweiz AG

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Technical Expert - Medical Devices

Job ID193132BRPosition TitleTechnical Expert - Medical DevicesDivisionPHARMABusiness UnitGlobal Tech OpsCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularJob DescriptionThe successful candidate will lead the technical development of parenteral delivery systems within Novartis Parenteral and Topical Device Development Team, from early phase activities up to commercialization and production scale up. In addition to outstanding project management skills, a strong technical background in devices and primary containers for parenteral is crucial, in order to support, monitor and challenge internal and external development partners.

Tasks and responsibilities would typically include:
• Thorough project planning
• Leading the definition of product requirements for delivery systems, e.g. drug/device combination products and medical devices
• Leading the collaboration with external development partners
- Monitor work progress according to plan
- Monitor, support and challenge technical development as well as test and verification work
- Monitor development and implementation of manufacturing processes
- Coordinate and monitor technical documentation
• Managing the collaboration with internal development partners and stakeholders
• Provide primary packaging and device expertise in a broader cross-functional drug product development team
• Evaluating and challenging technical solutions
• Ensuring a high quality Design History file
• Leading Risk management activities
• Leading and monitoring Human Factors Engineering activities
• Supporting and coordinating the manufacturing of clinical material and the production scale up
• Supporting cross functional project teams in the development, review and submission of regulatory dossiers
Minimum requirements• Bachelor’s or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education
• Fluency in English language is required
• Proficiency in German advantageous Other language skills, e.g. French, advantageous

An ideal candidate would have a relevant degree in engineering and at least 3 years of experience in a similar area, including:
• Good understanding of pharmaceutical development in general
• Experience in project / program management of complex projects
• Development and documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
• Considerable experience of managing external suppliers
• Mechanical engineering in general
- Product design/Design for manufacture
- Test and verification, incl. development of methods and equipment
• Good technical knowledge in primary containers, e.g. syringes and cartridges
• General understanding of Human Factors Engineering and Risk management