Required skills
- Product Development
- Single-Use Systems
- Biotechnology
- Biopharmaceutical
- Medical Technology
- Plastics Technology
- Fluid Technology
- Fluid Systems
- Hose Assemblies
- Filters
- Pumps
- Sensors
Nice to have:SAPPolarionVerificationValidationDesign ReviewsSystem Architecture
Languages: German
Job description
The role involves the independent and technical further development of existing concepts for single-use systems in the biopharmaceutical environment. Responsibilities include specifying fluid systems, hose assemblies, filters, pumps, and sensors, as well as creating and documenting product specifications and validation concepts.
Project overview
Senior Product Development Engineer – Single-Use Systems (Bioprocessing)
Responsibilities
Qualification:
Framework Data:
- Independent and technical further development of existing concepts for single-use systems in the biopharmaceutical environment
- Independent elaboration and specification of fluid systems, hose assemblies, filters, pumps, and sensors, taking into account technical, quality-related, and regulatory requirements
- Independent evaluation of technical solution approaches as well as execution and documentation of design reviews and development decisions
- Creation and maintenance of product specifications, bills of materials, and development and system documentation
- Creation and documentation of verification and validation concepts, including evaluation and tracking of test results
- Coordination with interdisciplinary departments to ensure a production-ready and validatable development solution
- Documented handover of development results as a basis for prototype construction and subsequent industrialization
- Several years of experience in the product development of technical systems, ideally in the field of biotechnology, medical technology, pharmaceuticals, or comparable regulated industries
- Sound knowledge in the areas of plastics technology, fluid technology, or single-use systems
- Experience in the development and evaluation of complex system architectures and technical product solutions
- Knowledge of design reviews, development processes, and technical decision-making and change processes
- Experience with verification, validation, and quality-related development documentation
- Understanding of hose systems, filtration, pumps, sensors, and associated system components
- Confident use of SAP and ideally experience with Polarion
- Very good German and English skills
Project details
Immediately
12 months with option to extend
Utilization: Full-time (5 days per week)
Remote Share: Approx. 50%
Lower Saxony
- Start: ab sofort
- Duration: 12 Monate
- Remote: hybrid
- Location: Hannover, Deutschland, DE
- Languages: German
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