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.

Ihre Aufgaben

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

Was Sie mitbringen

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

Rahmenbedingungen

Option auf Festanstellung nach dem Einsatz, wenn beide Seiten wollen

Was Sie erwartet

3–6 months interim, then a permanent position

Technologien

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

So bewerben Sie sich

Sie bewerben sich mit Ihrem Try&Hire-Profil: Lebenslauf hochladen, Angaben prüfen, Eckdaten und Verfügbarkeit eintragen. Ein kurzes Vorstellungsvideo ist freiwillig, hilft aber. Unser Team meldet sich, wenn Ihr Profil zum Einsatz passt.

Senior Container Closure Expert (PFS / Cartridges)