Mechanical Design Engineer – Aseptic Isolator Tooling

Capgemini; Opfikon; Hybrid; CHF 110,000 - 140,000; Full time

Benefits offered by this job

5 weeks vacation

Employee referral bonus

Company shares program

Annual fitness subscription

Job summary

Capgemini Engineering seeks an experienced Mechanical Design Engineer to design, develop, and implement custom tooling and equipment for aseptic fill & finish operations within an isolator environment. You will ensure First Air protection and Annex 1 compliance while improving operator safety and process robustness.

Responsibilities include creating 3D CAD models and drawings in SolidWorks, performing design reviews and risk assessments, supporting FAT/SAT and commissioning, and collaborating

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Mechatronics, or related field.
• 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 is a plus.
• Knowledge of isolator technology and aseptic processing is a plus.

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.

Skills

Problem-solving mindset

Independent work in multidisciplinary,

Education

Bachelor's or Master's in Mechanical Engineering/Mechatronics

Tools

SolidWorks

Job description

Capgemini Engineering seeks an experienced Mechanical Design Engineer to design, develop, and implement custom tooling and equipment for aseptic fill & finish operations within an isolator environment. You will ensure First Air protection and Annex 1 compliance while improving operator safety and process robustness.

Responsibilities include creating 3D CAD models and drawings in SolidWorks, performing design reviews and risk assessments, supporting FAT/SAT and commissioning, and collaborating