Dipl.-Ing. Markus Bee

Planning and execution of technical tests and clinical sample production for development. Collaboration in project teams for the implementation of customer projects as a process expert. Management of employees in various production areas, mass preparation, coating, assembly and primary packaging.

Planning and qualification of machines for automated production in hygiene zones. Qualification of inspection systems by means of measurement system analysis. Evaluation of new processes and optimization of existing processes.

Check of qualifications and validations at suppliers. Evaluate of risk analysis for medical devices using method like FMEA, HACCP, 5M, Ishikawa-diagrams according to standards ISO 11607, ISO 10993 and FDA guidelines. Planning and preparation of sterilization validation for radiation sterilization (ISO 11137) and EO sterilization (ISO 11135), including the microbiological tests to ISO 11737 and USP 85 (Bacterial endotoxin test). Planning and preparation of the methods for measuring particles (USP788).

Development and validation of processes. Creation of production concepts. Evaluation and optimization of design concepts from the perspective of a highly automated production, taking account of GMP and GAMP. Support the sterilization process of medical devices and primary packaging for pharmaceutical products.

Implementation of a new production line: "needles for injection pens" Development of procedures and processes for automated cleanroom production. Creating specifications and qualification documents in accordance with GMP standard. Qualification of automated production lines. Validation of processes.

Qualification and validation of equipment and tools to GMP standard. Planning of resources in an automated manufacturing.

Implementation of a new production line: "sensor/actuator cabling" Project management of electromechanical assemblies from the proposal phase through to handover into production. Budgeting and scheduling of strategic and customer-specific projects. Planning of resources in an automated manufacturing. Planning and acceptance of injection molds with the involvement of FEA software. Development and production calculations of new product groups. Defining procedures in the development process.

Project management of connectors and cable harnesses, from proposal phase to serial over to the international production facilities. Support of injection molds, preparation of specifications, definition of injection parameters, handover to production. Fixing problems at the production site.

as part of temporary-employment agency work 12/1997 Dornier in Friedrichshafen -Creation of logistics concepts 01/1998-12.1998 Mannesmann VDO in Villingen-Schwenningen -Construction of tachographs for commercial vehicles

Diploma thesis: Analysis of the process behavior of distance sleeves of a co-rotating double screw extruder based on the FEM