Senior Container Closure Expert (PFS / Cartridges)

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche Global Technical Development invites you to join the Device Engineering team, driving design controls and solving complex device challenges to bring safe, high‑quality drug delivery systems to patients. You will lead cross‑functional collaboration with QA, Regulatory Affairs, Clinical and Commercial teams, applying expertise in primary containers and E&L to define robust specifications.

With a university degree and 5+ years in mechanical engineering for drug delivery, you will influence

Qualifikationen

• University degree in engineering from an accredited institution.
• 5+ years of mechanical engineering and drug delivery device development experience.
• Expertise in container closure systems, especially prefilled syringes and cartridges.
• Strong leadership, communication and cross‑functional collaboration skills.

Aufgaben

• Lead internal and external technical investigations, resolving design‑related device issues.
• Author design control documentation and ensure compliance with regulatory standards.
• Collaborate with QA, Regulatory Affairs, Clinical and Commercial teams to advance development.
• Apply materials science and E&L knowledge to define robust packaging specifications.

Kenntnisse

Mechanical engineering

Drug delivery devices

Container closure systems

Cross-functional leadership

Regulatory knowledge

Design controls

Problem solving

English fluency

Ausbildung

BSc or MSc in engineering

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The 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 Requirements 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 <1207> / USP <381> / USP <660>).

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.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.