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At Capgemini Engineering, you will join a global team of engineers, scientists, and architects supporting the design, development, and implementation of custom tooling and equipment for aseptic fill & finish operations within an isolator environment. The focus is on developing solutions that maintain First Air protection, support Annex 1 compliance, and improve operator safety, ergonomics, and process robustness.
Tasks
- Design and develop custom isolator tools, fixtures, change parts, and operator aids for aseptic fill & finish operations.
- Ensure designs comply with Annex 1 principles and maintain protection of critical zones and First Air.
- Create and review 3D CAD models, assemblies, drawings, and technical documentation.
- Perform design reviews, risk assessments, and feasibility studies.
- Evaluate operator interventions and develop engineering controls to minimize contamination risks.
- Support FAT, SAT, commissioning, and implementation activities.
- Collaborate with equipment suppliers and engineering partners during development and procurement phases.
- Apply hygienic design principles and GMP requirements throughout the design lifecycle.
- Support continuous improvement initiatives for isolator operations and aseptic processes.
Requirements
- Bachelor's or Master's degree in Mechanical Engineering, Mechatronics, or a related engineering discipline.
- Several years of experience in machine design, special-purpose machinery, pharmaceutical equipment, or aseptic manufacturing environments.
- Strong CAD skills (SolidWorks or equivalent).
- Experience creating manufacturing drawings and technical documentation.
- Understanding of mechanical design, materials, tolerances, and fabrication methods.
- Ability to work independently in multidisciplinary project teams.
- Experience with pharmaceutical fill & finish equipment (preferred).
- Knowledge of isolator technology and aseptic processing (preferred).
- Understanding of EU GMP Annex 1 requirements (preferred).
- Experience with airflow concepts, contamination control, and First Air protection (preferred).
- Experience supporting qualification and validation activities in GMP environments (preferred).
- Familiarity with ergonomic design and human-machine interactions within isolators (preferred).
- Strong engineering judgement.
- Problem-solving mindset.
- Risk-based decision making.
- Excellent communication skills.
- Ability to challenge designs from a contamination control perspective.
- Hands-on approach during testing and implementation.
Benefits
- Access to over 60,000 hours of world-class training at the engineering academy, supporting your growth from day one.
- Digital campus for continuous learning in areas such as Generative AI, data science, and sustainability.
- Hybrid working for flexibility and work-life balance.
- Diverse teams fostering innovation and inclusive collaboration.
- 5 weeks of vacation.
- Employee referral bonus.
- Company shares program.
- Annual contribution to a fitness subscription.
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Über uns
Capgemini Suisse SA ist die Schweizer Gesellschaft der internationalen Capgemini-Gruppe und erbringt Dienstleistungen in den Bereichen Technologie, Beratung, digitale Transformation und Engineering. Das Unternehmen unterstützt Unternehmen und Organisationen bei IT-Strategie, Softwareentwicklung, Cloud, Data & AI, Cybersecurity, Business Transformation, Digital Customer Experience und technologischer Umsetzung. Capgemini Schweiz ist an den Standorten Zürich, Basel, Genf und Lausanne präsent und verbindet lokale Beratung mit den Ressourcen und Fachkompetenzen des globalen Capgemini-Netzwerks.