Dein persönlicher KI-Karriere-Agent
Designing custom isolator tools and fixtures for aseptic manufacturing. Several years of machine design experience required. Hybrid working, 60,000 hours of training.
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Anforderungen
- Bachelor's or Master's degree in Mechanical Engineering, Mechatronics, or related engineering
- Several years of experience in machine design, special-purpose machinery, pharmaceutical equipment, or aseptic manufacturing
- Strong CAD skills (SolidWorks or equivalent)
- Experience creating manufacturing drawings and technical documentation
- Understanding of mechanical design, materials, tolerances, and fabrication
- Ability to work independently in multidisciplinary project teams
- 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
- Strong engineering judgement
- Problem-solving mindset
- Risk-based decision making
- Excellent communication skills
- Ability to challenge designs from contamination control perspective
- Hands-on approach during testing and implementation
Aufgaben
- Design and develop custom isolator tools, fixtures, change parts, and operator aids
- Ensure designs comply with Annex 1 principles and maintain critical zone protection
- 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
- Apply hygienic design principles and GMP requirements throughout the design lifecycle
- Support continuous improvement initiatives for isolator operations and aseptic processes
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- 60,000 hours of training
- Hybrid working
- Work-life balance
- Diverse teams
- Inclusive collaboration
- Employee referral bonus
- Company shares program
- Annual fitness contribution
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Capgemini erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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