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The Position
The Equipment Engineering team provides technical leadership and accountability for high‑end automated manufacturing systems. We support PT, CMOs and Affiliates in delivering complex capital projects, ensuring that our packaging and assembly infrastructure meets the highest global standards for pharmaceutical and combination products.
The Opportunity
Provide technical leadership and end‑to‑end accountability for complex automated manufacturing systems for Drug Products and Combination Products
Lead the independent planning, design, specification, and procurement of automated device assembly and high‑speed packaging lines
Manage the complete project lifecycle from concept development through detailed engineering to FAT/SAT, qualification and commercial ramp‑up
Oversee sub‑project budgets, schedules and resource planning while ensuring alignment with key stakeholders and the project management team
Act as the primary technical and commercial interface for equipment suppliers, automation integrators and specialised technology providers
Drive engineering for state‑of‑the‑art assembly systems for pre‑filled syringes, autoinjectors and pen injectors in compliance with ISO 13485 and EU MDR
Lead packaging system projects including blister forming, cartoning, vision inspection and serialization to ensure full traceability and data integrity
Define and execute qualification strategies (IQ/OQ) in compliance with EU GMP, FDA CFR 21 and GAMP 5 standards
Act as a technical Subject Matter Expert (SME) during regulatory inspections and audits to ensure constant inspection readiness
Who you are
You are a highly disciplined technical leader with a strong sense of accountability and the ability to manage complex, multidisciplinary projects. You possess exceptional problem‑solving skills and the analytical mindset required to resolve technical issues in operationally demanding environments, while your communication style allows you to align diverse stakeholders and lead external partners effectively.
Qualifications and experience
Bachelor’s degree in Mechanical Engineering, Mechatronics or a related technical discipline
8 to 12 years of experience in engineering, preferably within the pharmaceutical, biotech or medtech industries
Extensive expertise in collaborating with equipment manufacturers, executing FAT/SAT and managing commissioning and qualification activities
Profound knowledge of regulatory requirements (FDA, EMA, GMP) and standards for combination products (ISO 13485, EU MDR)
Demonstrated ability to execute highly complex scopes within mid‑sized to large‑scale investment projects
Proficient in English and German
Willingness to travel (50 % or more) and a readiness for international assignments of 1 to 3 years
Relocation benefits are not offered for this position.
Roche is an Equal Opportunity Employer.
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