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.

I Suoi compiti

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

Che cosa porta con sé

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

Condizioni quadro

Opzione di assunzione a tempo indeterminato dopo l'incarico, se entrambe le parti lo desiderano

Che cosa La aspetta

3–6 months interim, then a permanent position

Tecnologie

ISO 13485
21 CFR 820
ISO 14971
21 CFR 820.30
21 CFR Part 4
ISO 11040
ISO 11608
USP

Come candidarsi

Si candida con il Suo profilo Try&Hire: carichi il CV, verifichi i dati, inserisca i dati principali e la disponibilità. Un breve video di presentazione è facoltativo, ma aiuta. Il nostro team La contatterà se il Suo profilo è adatto all'incarico.

Senior Container Closure Expert (PFS / Cartridges)