Capgemini

Global consulting, technology services, outsourcing

Mechanical Design Engineer

Design EngineeringUpdated on Nov 14

Full-timeOpfikon, Switzerland

About the Job

Requirements

A bachelor's or master's degree in Mechanical Engineering, Mechatronics, or a related engineering discipline is required.
Several years of experience in machine design, special-purpose machinery, pharmaceutical equipment, or aseptic manufacturing environments is required.
Strong computer-aided design skills using SolidWorks or an equivalent tool are required.
Experience creating manufacturing drawings and technical documentation is required.
Understanding of mechanical design, materials, tolerances, and fabrication methods is required.
Ability to work independently in multidisciplinary project teams is required.
Strong engineering judgment is required.
A problem-solving mindset is required.
Risk-based decision-making ability is required.
Excellent communication skills are required.
Ability to challenge designs from a contamination control perspective is required.
A hands-on approach during testing and implementation is required.

Responsibilities

Design and develop custom isolator tools, fixtures, change parts, and operator aids for aseptic fill-and-finish operations.
Ensure designs comply with Annex 1 principles and maintain protection of critical zones and First Air.
Create and review 3D computer-aided design 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 factory acceptance testing, site acceptance testing, commissioning, and implementation activities.
Collaborate with equipment suppliers and engineering partners during development and procurement phases.
Apply hygienic design principles and good manufacturing practice requirements throughout the design lifecycle.
Support continuous improvement initiatives for isolator operations and aseptic processes.
Work closely with Process Engineering, Manufacturing, Automation, Validation, Quality, and external equipment suppliers.

Desired Qualifications

Experience with pharmaceutical fill-and-finish equipment is preferred.
Knowledge of isolator technology and aseptic processing is preferred.
Understanding of EU Good Manufacturing Practice Annex 1 requirements is preferred.
Experience with airflow concepts, contamination control, and First Air protection is preferred.
Experience supporting qualification and validation activities in good manufacturing practice environments is preferred.
Familiarity with ergonomic design and human-machine interactions within isolators is preferred.

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. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

YOUR ROLE

We 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 EXPERIENCE

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.

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.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size: 10,001+
Company stage: IPO
Headquarters: Paris, France
Founded: 1967

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