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

Навыки

• Приёмочное тестирование
• Лидерство
• Решение задач
• Управление проектами

О компании и продукте

• 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.

Требования

• 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?
• 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
• 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

Условия

• 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

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