Device & Packaging Senior Expert Engineering at Novartis in Basel

Keywords

• pharmaceutical packaging
• drug delivery systems
• medical devices
• Design History File
• Basel

Summary

Support the technical development of packaging and delivery systems for new oral drugs at Novartis in Basel, from early phase activities through to commercialization and production scale-up.

Job Description

Novartis in Basel is looking for a Senior Expert to support the technical development of packaging and delivery systems for new oral drugs, from early phase activities through to commercialization and production scale-up within the Oral Packaging & Delivery Systems Group.

• Support the definition of product requirements and qualification of oral packaging and drug delivery systems, including drug/device combination products and medical devices.
• Monitor, support and challenge technical development, test and verification work, and manufacturing process implementation with internal and external partners.
• Provide primary packaging and device expertise within a cross-functional drug product development team.
• Support and coordinate the manufacturing of clinical material and production scale-up.
• Lead risk management activities and manage Human Factors Engineering processes.
• Author technical documentation and ensure a high-quality Design History File, including transfer to production.
• Support cross-functional project teams in the development, review and submission of regulatory dossiers.

• Bachelor's or Master's degree in Packaging Science/Engineering, Mechanical Engineering, or equivalent university-level engineering education.
• At least 7 years' experience in supporting or leading pharmaceutical packaging or drug delivery device development teams.
• Understanding of medical device regulations (FDA 21 CFR 820, EU Medical Device Directive/Regulation).
• Experience with technical documentation, Design Control processes, and GMP aspects.
• Fluency in English; proficiency in German or French is advantageous.
• Strong communication and conflict-solving skills.

Novartis offers a competitive base salary, a performance-based bonus, insurance and retirement plans, wellbeing resources, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave.