Required skills
- Product Development
- Single-Use Systems
- Bioprocessing
- Fluidics
- Plastics Technology
- Medical Technology
- Pharmaceutical Industry
- SAP
- Design Reviews
- Verification
- Validation
- Technical Documentation
Nice to have:Polarion
Languages: German
Job description
Seeking a Senior Product Development Engineer with expertise in Single-Use Systems for biopharmaceutical applications. The role involves developing and specifying fluid handling systems, assemblies, and components, with a focus on technical, quality, and regulatory requirements.
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 handling 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 validation-capable development solution
- 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: ASAP
- Duration: 12 months
- Remote: hybrid
- Location: Niedersachsen, Germany, DE
- Languages: German
Indexed by 9am's meta-search. You are a job provider? Claim or manage this listing
Found on K-Recruiting