Greater Tubingen Area
• Coordinating and implementing the qualification, validation, training, optimization and deficiency correction for two new production lines in USP and DSP according to internal quality processes • Creation, implementation and validation of recipes for USP and DSP areas with Simatic BATCH • Technical coordination and execution of the implementation of a flexible small- and large-scale production line based on an existing production line • Introducing a Process Automation System (>40 Equipments) complying to ISA-88 Standard, Performing Software Validation according to GAMP 5 proofing functionality.
• Technical management of a new 30g production line in an existing building • Planning and coordination of turnarounds for 2 GMP-production lines with > 50 equipments with parallel renewal of several process plants • Collaboration in setting up the new engineering department – creating specifications and creating processes • Implementation of an audit trail and specific turnaround planning scripts in the equipment database filemaker • Developing a process for the layout CAD management • Creation of 3D models of the GMP production lines to improve planning, coordination and trainings
• Responsible for the utility planning, coordination and realization in an reconstruction of a DSP production line • Supporting a Basic-Design for an insulin-production facility in Brazil.