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

Roche; Kaiseraugst; Vor Ort; CHF 140.000 - 200.000; Vollzeit

Zusammenfassung

Roche is seeking a senior Equipment Engineering leader to drive end-to-end ownership of complex automated manufacturing lines for Drug Products and Combination Products. You will guide design evaluation, procurement, integration, and qualification across multi-site operations, ensuring adherence to global standards.

You will manage budgets and schedules, oversee interfaces with suppliers, and act as SME for equipment safety during inspections, bringing deep expertise in ISO 13485, EU MDR, and

Qualifikationen

• Bachelor’s or Master’s Degree in Mechanical Engineering, Mechatronics, Automation Engineering or related technical discipline.
• 8–12 years of hands-on experience in equipment engineering, special machine construction, or custom automation in pharma/biotech/medtech.
• Deep technical expertise in managing machine suppliers, FAT/SAT, and mechanical commissioning onsite.
• Strong knowledge of machinery directives, equipment qualification (GMP, GAMP 5), and ISO 13485/EU MDR requirements.
• Proven track record delivering complex equipment engineering projects within mid- to large-scale capital investments.
• Proficient in English; German is an advantage.

Aufgaben

• Provide technical leadership and end-to-end equipment engineering accountability for complex automated manufacturing lines.
• Lead mechanical design evaluation, technical specification, procurement, and integration of customized assembly machines and high-speed packaging equipment.
• Manage the complete project lifecycle from concept through FAT/SAT to qualification and ramp-up.
• Drive mechanical and automation engineering for state-of-the-art assembly systems in compliance with ISO 13485 and EU MDR.
• Lead specialized equipment projects including high-speed cartoning machines, assembly automation, vision inspection, and inline serialization.
• Oversee sub-project budgets, schedules, and engineering resource planning; ensure alignment with suppliers and internal PM.
• Act as the primary technical and commercial interface for equipment suppliers, automation integrators, and technology providers.
• Define and execute equipment qualification strategies (IQ/OQ) per EU GMP, FDA CFR 21, and GAMP 5.
• Serve as SME for manufacturing equipment and machine safety during regulatory inspections and audits.

Kenntnisse

Technical leadership

Project management

Problem solving

Stakeholder communication

Regulatory awareness

Ausbildung

Bachelor’s or Master’s Degree in Mechanical Engineering, Mechatronics, Automation Engineering

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. 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 for machinery engineering from concept development and technical vendor selection through FAT/SAT to 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, schedules, 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 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
• 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.