Beschreibung

This role leads engineering and technical strategy for primary container closure systems used in drug delivery devices, such as prefilled syringes and cartridges, within a pharmaceutical development environment.

Tasks

• Act as technical lead and subject matter expert for combination products and medical devices from development to market
• Apply expertise in container materials and extractables/leachables profiles to define packaging specifications
• Develop and evaluate container closure design solutions for device integration and integrity
• Provide technical oversight to external partners on mechanical designs for combination products
• Lead technical investigations and root cause analysis for device and container issues
• Author design control documentation, conformity assessments and risk management documentation

Profile

• University degree (BSc or MSc) in engineering or a related technical discipline
• 5+ years of experience in mechanical engineering and drug delivery device development in regulated environments
• Strong expertise in container closure systems, prefilled syringes and cartridges
• Experience in fill/finish technology including stoppering
• Knowledge of regulations and standards for combination products and medical devices
• Experience navigating Health Authority interactions and regulatory submissions
• Fluency in English required; German proficiency is a plus

Offer

• 3–6 months interim, then a permanent position

Company

Pharmaceutical development