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

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

Zusammenfassung

Roche is seeking a highly skilled Equipment Engineering leader to drive end-to-end responsibility for automated manufacturing lines. You will guide mechanical design, procurement, integration of high-speed packaging equipment, and manage the full lifecycle from concept to ramp-up.

Required are 8–12 years in pharma/biotech equipment engineering, FAT/SAT and on-site commissioning, and solid knowledge of GMP, GAMP 5, ISO 13485, EU MDR. English proficiency is essential, German a plus.

Qualifikationen

• Bachelor’s or Master’s in Mechanical Engineering, Mechatronics, or Automation Engineering.
• 8–12 years in equipment engineering or automation within pharma/biotech/medtech.
• Experience with FAT/SAT and on-site commissioning.
• Knowledge of GMP, GAMP 5 and ISO 13485 / EU MDR.
• English proficiency; German is a plus.

Aufgaben

• Provide technical leadership and end-to-end equipment engineering accountability for complex automated manufacturing lines.
• Lead mechanical design evaluation, specification, procurement, and integration of assembly machines and high-speed packaging equipment.
• Manage lifecycle from concept to FAT/SAT qualification and ramp-up.
• Drive equipment for assembly systems in pre-filled syringes, autoinjectors, and pen injectors.
• Oversee budgets, schedules and resource planning; align with suppliers and internal PM.
• Interface with equipment suppliers, automation integrators, and technology providers.
• Define and execute IQ/OQ qualification strategies per EU GMP, FDA CFR 21, GAMP 5.
• Act as technical SME for manufacturing equipment and machine safety during inspections.

Kenntnisse

Technical leadership

Mechanical engineering

Automation engineering

GMP/GAMP5 knowledge

English proficiency

Ausbildung

Bachelor’s or Master’s in Mechanical/Mechatronics/Automation

Tools

FAT/SAT processes

Regulatory standards ISO 13485 / EU MDR

GMP/GAMP5 knowledge

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

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 equipment engineering accountability for complex automated manufacturing lines for Drug Products and Combination Products.
• Lead the independent mechanical design evaluation, technical specification, procurement, and integration of customized assembly machines and high-speed packaging equipment.
• Manage the complete project lifecycle from concept development and technical vendor selection through FAT/SAT and qualification and commercial ramp-up.
• Drive mechanical 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.
• Lead specialized equipment projects including high-speed cartoning machines, primary/secondary assembly automation, vision inspection systems and inline serialization units.
• Oversee sub-project budgets, schedule and engineering resource planning while ensuring seamless 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 execute equipment qualification strategies (IQ/OQ) in compliance with EU GMP, FDA CFR 21, and GAMP 5 standards.
• Act as a technical 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.
• Proficient in English is a must, German is an advantage.

Are you ready to design and engineer the machinery that impacts our patients' lives?

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. 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.