Senior Container Closure Expert (PFS / Cartridges)

Job description

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. Act as technical project leader or technical expert to successfully bring combination products and medical devices to the market Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product Collaborate with external partners providing technical oversight on mechanical designs for combination products to ensure high performance, design robustness and innovation. Lead internal and external technical investigations, swiftly resolve design related device issues by applying structured problem solving methodologies. 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. Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30) 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). Hands-on expertise in pen injector and autoinjector development throughout the entire product lifecycle. Strong background in container closure systems, specifically prefilled syringes and cartridges for parenteral drug delivery. 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. 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.