Device & Packaging Senior Expert Engineering

Salary Range: CHF93,800.00 - CHF174,200.00   Job Description Summary Location: Basel, Switzerland #onsite Role Purpose: The successful candidate for this position will need to be able to support the technical development of packaging and delivery systems for new oral drugs within the Novartis Oral Packaging & Delivery Systems Group, from early phase activities up to commercialization and production scale up. In addition to outstanding inter-personal skills, a strong technical background in pharmaceutical packaging and drug delivery medical devices is crucial to be able to support, monitor and challenge internal and external development partners.   Job Description Tasks and responsibilities would typically include: • Thorough project planning • Supporting the definition of product requirements and qualification of oral packaging and drug delivery systems, e.g. drug/device combination products and medical devices • Supporting the collaboration with other development business 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, • Providing primary packaging and device expertise in a broader cross-functional drug product development team, • Evaluating and challenging technical solutions, • 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, • Leading Risk management activities, • Managing and monitoring Human Factors Engineering activities, • Monitoring of design verification activities (in-house), • Leading and authoring technical documentation, • Ensuring a high-quality Design History file, • Transfer of Design History File to production. Requirements Bachelor’s or Master’s degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education. An ideal candidate would have a relevant degree in engineering and at least 7 years’ experience in supporting or leading pharmaceutical packaging or drug delivery device development technical teams. Fluency in English language is required. Proficiency in German/French advantageous. Experience desire d • Good understanding of pharmaceutical development in general, • Experience in supporting complex projects / programs, • Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive, EU Medical Device Regulation), • Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable Regulatory, QA and GMP aspects, • Mechanical/Industrial engineering in general • Product design/Design for manufacture • Test and verification, incl. development of methods and equipment • General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements, • Good communication and conflict solving skills. Benefits & Rewards   At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.   Expected Annual Base Salary Range for role: CHF93,800 to CHF174,200   The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.   In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.   The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive