Single-Use Design Consultant

Project overview

Evaluation and technical elaboration of existing designs for single-use assemblies in the biopharmaceutical environment. Definition and specification of plastic fluid lines, hose systems, and relevant single-use components, taking into account technical, quality-related, and regulatory requirements. Creation and maintenance of product specifications, parts lists, development documentation, and SAP documentation. Documentation of technical evaluations, design decisions, change requests, as well as relevant quality and production requirements.

Creation and documentation of verification and validation concepts, as well as evaluation and documentation of test results. Provision of a documented and coordinated development solution as a basis for prototype construction and further industrialization. Application of SAP and Polarion tools.

Requirements

Technical background in product development, plastics technology, or fluid technology. Knowledge of design reviews, technical decision-making processes, and the technical evaluation of technical development solutions. Understanding of design concepts, system architectures, and technical solution options in the product development environment. Knowledge of single-use systems, fluid management systems, or comparable technical product solutions. Understanding of hose systems, plastic components, filtration, pumps, sensor technology, and associated system architectures.

Understanding of quality-related and regulated development processes, for example in medical technology, the pharmaceutical industry, biotechnology, or comparable sectors.

Project details

D3 Göttingen / 50% Remote.

immediately.

12 months++

• Start: flexible
• Location: DE
• Languages: German