Mechanical Design Engineer in Opfikon

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential.

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YOUR ROLEWe are seeking an experienced Mechanical Design Engineer to support the design, development, and implementation of custom tooling and equipment for aseptic fill & finish operations within an isolator environment.

The role focuses on developing solutions that maintain First Air protection, support Annex 1 compliance, and improve operator safety, ergonomics, and process robustness.

The successful candidate will work closely with Process Engineering, Manufacturing, Automation, Validation, Quality, and external equipment suppliers.

Your Responsibilities 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.

YOUR SKILLS AND EXPERIENCEBachelor'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 (Solid Works 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.

Preferred Qualifications Experience with pharmaceutical fill & finish equipment.

Knowledge of isolator technology and aseptic processing.

Understanding of EU GMP Annex 1 requirements.

Experience with airflow concepts, contamination control, and First Air protection.

Experience supporting qualification and validation activities in GMP environments.

Familiarity with ergonomic design and human-machine interactions within isolators.

Key Competencies 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 WHAT YOU’LL LOVE ABOUT WORKING HERE?At our engineering academy, you’ll have access to over 60,000 hours of world-class training - designed to fuel your growth from day one.

Whether you're diving into Generative AI, data science, or sustainability, our digital campus supports your learning journey every step of the way; Experience the benefits of hybrid working, offering flexibility and ensuring work-life balance; Harness the strength of diverse teams, fostering innovation and inclusive collaboration; We offer additional benefits such as 5 weeks of vacation, Employee referral bonus, Company shares program and Annual contribution to a fitness subscription.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society.

It is a responsible and diverse group of 340,000 team members in more than 50 countries.

With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs.

It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
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