Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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-endequipment engineering accountability for complex automated manufacturinglines for Drug Products and Combination Products.
- Lead the independentmechanical design evaluation, technical specification, procurement, and integration of customized assembly machines and high-speed packaging equipment.
- Manage the complete project lifecycle formachinery engineering from concept development andtechnical vendor selection through FAT/SAT to qualification and commercial ramp-up.
- Drivemechanical and automation engineering for state-of-the-art assembly systems for pre-filled syringes, autoinjectors, and pen injectors in compliance with ISO 13485 and EU MDR.
- Leadspecialized equipment projects including high-speed cartoning machines, primary/secondary assembly automation, vision inspection systems, and inline serialization units.
- Oversee sub-project budgets, schedules, andengineering resource planning while ensuringseamless technical alignment with machine suppliers and internal project management.
- Act as the primary technical and commercial interface for equipment suppliers, automation integrators, and specialized technology providers.
- Define and executeequipment qualification strategies (IQ/OQ) in compliance with EU GMP, FDA CFR 21, and GAMP 5 standards.
- Act as a technical Subject Matter Expert (SME)for manufacturing equipment and machine safety during regulatory inspections and audits.
Who You Are
You are a highly disciplined technical project leader with a strong background in mechanical machinery engineering CAPEX projects and a passion for automated production equipment. You possess exceptional technical problem-solving skills and the hands-on mindset required to solve complex mechanical, automation, and line-integration challenges, while your communication style allows you to effectively direct machine manufacturers and key internal stakeholders.
In addition, you possess the following qualifications and experience:
- Bachelor’s or Master’s Degree in Mechanical Engineering, Mechatronics, Automation Engineering, or a related technical discipline.
- 8 to 12 years of hands-on experience in equipment engineering, special machine construction, or custom automation within the pharmaceutical, biotech, or medtech industries.
- Deep technical expertise in managing machine suppliers, executing factory and site acceptance testing (FAT/SAT), and leading mechanical commissioning on-site.
- Strong knowledge of machinery directives, equipment qualification (GMP, GAMP 5), and relevant standards for combination product manufacturing equipment (ISO 13485, EU MDR).
- Proven track record of delivering complex equipment engineering projects within mid-sized to large-scale capital investment projects.
- Proficientin English is a must, German is an advantage
Are you ready to design and engineer the machinery that impacts our patients' lives? 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.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
