Device & Packaging Senior Expert Engineer

Supports the technical development of packaging and drug delivery systems for oral drugs, from early phase through commercialization and production scale-up.

Tasks

• Support project planning and definition of product requirements for packaging and drug delivery systems
• Monitor and challenge technical development, test and verification work with external partners
• Provide primary packaging and device expertise in cross-functional drug product teams
• Support manufacturing of clinical material and production scale-up
• Support regulatory dossier development, review and submission
• Lead risk management activities and manage Human Factors Engineering
• Author technical documentation and ensure a high-quality Design History File

Profile

• Bachelor's or Master's degree in Packaging Science/Engineering, Mechanical Engineering or related engineering field
• At least 7 years experience supporting or leading pharmaceutical packaging or drug delivery device development
• Fluency in English required; German/French proficiency advantageous
• Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive, EU Medical Device Regulation)
• Experience in product design, design for manufacture, test and verification
• General understanding of Human Factors Engineering and risk management processes

Offer

• 3–6 months interim, then a permanent position
• Onsite in Basel

Company

Pharmaceutical development