Senior Technical Sub-Project Manager Packaging & Assembly (EU)

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

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 specialized 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.

In addition, you possess the following 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. 

Are you ready to make a difference for our patients? We are looking forward to your application – join us now and become part of our journey!

 

 

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Kaiseraugst. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

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.