Mechanical Design Engineer

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.

• 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.

• 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.

• 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.

Capgemini Engineering is a global business and technology transformation partner with 340,000 team members in more than 50 countries. With over 55 years of heritage, Capgemini delivers end-to-end services and solutions, leveraging strengths in AI, generative AI, cloud, data, and deep industry expertise.