Senior Container Closure Expert (PFS / Cartridges)

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La position Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate is to expertly deliver the pipeline and supply quality products to patients. The Device Development department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio.

Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. Device Engineering combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities. The opportunity: This hands-on role drives engineering excellence by applying design controls, solving complex device engineering challenges, and providing strategic technical guidance to ensure robust product development and compliance.

In this role, you will engage in extensive cross-functional collaboration, particularly with Quality Assurance, Regulatory Affairs, Clinical, and Commercial teams. This role reports to the Section Head of Device Engineering and is integrated into the Roche Device Development function.

• Serve as technical lead and subject matter expert to bring combination products and medical devices from development to market.
• Apply deep expertise in primary container materials (Type I glass, COP/COC polymers, elastomers, functional coatings) and extractables/leachables (E&L) profiles to establish robust technical specifications for primary packaging systems.
• Develop and evaluate container closure design solutions to ensure seamless device integration, container integrity, fill/finish expertise and sustained technical performance.
• External Technical Oversight: Collaborate with external partners providing technical oversight on mechanical designs for combination products to ensure high performance, design robustness and innovation.
• Structured Problem Solving & RCA: Lead internal and external technical investigations, swiftly resolve design-related device and primary container issues (e.g., break-loose/glide force, glass damage mechanisms, sub-visible particles, stopper movement) by applying structured problem solving methodologies.
• Design Control & Regulatory Authoring: Author design control documentation (e.g. Design Development Plans, User

Specifications, Design Inputs, Design Outputs, Design Verification Plans), conformity assessments and risk management documentation.

• Standards & Compliance Application: Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21 CFR 820, ISO 14971, 21 CFR 820.30, 21 CFR Part 4, ISO 11040, ISO 11608, USP / USP / USP ). Who you are:
• University degree (BSc or MSc) in engineering or a related technical discipline from an accredited institution.
• 5+ years of experience in mechanical engineering and drug delivery device development within pharma or highly regulated environments (cGxP, QSR).
• Strong expertise in container closure systems, specifically prefilled syringes (PFS) and cartridges for parenteral drug delivery (including CCI testing, elastomer/coating chemistry, staked-needle integration, and dimensional stack-ups).
• Experience in fill / finish technology incl. stoppering
• Proven technical leadership and advanced problem-solving capabilities in cross-functional team environments.
• Solid understanding of materials science applied to drug delivery systems, with expertise in damage mechanisms, defect identification, and performance testing.
• Deep knowledge of regulations, industry standards, and guidance for combination products and medical devices on a global scale.
• Direct experience navigating Health Authority interactions and managing regulatory submissions (including Module 3 authoring for IND/IMPD and NDA/BLA).
• Technical proficiency in parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, and reliability engineering to resolve complex issues.
• Excellent communication skills, strategic thinking, and strong documentation/presentation capabilities to effectively influence stakeholders.
• Fluency in English is required for this global role; German proficiency is a plus. Qui nous sommes Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial. Construisons ensemble un avenir plus sain. Roche est un employeur offrant l'équité en matière d'emploi.