• Project management for updating regulatory requirements in the pharmaceutical production field (GMP Annex 1), initial set up of CCS, project management in the design and implementation of new cleanroom garments as well in the renovation of cleanroom airlocks

2020 - 2023: Project management and consulting on consolidation processes for sterile packaging

Customer: manufacturer of medical devices

Place of work: Lake Constance region and Manchester (UK) area

Tasks:

• Project management and consulting on consolidation processes for sterile packaging due to the implementation of the Medical Device Regulation (MDR), development of a soft blister packaging for single-use medical devices, project management in the relocation of medical device production, validation of a sterile packaging for single-use items according to DIN ISO 11607-1 and -2

2014 - 2018: Dpt. Of Global Process Engineering

Role: Senior Project Manager

Customer: BBraun Avitum Saxonia GmbH,

Tasks:

Senior Project Manager for engineering and procurement projects with the following areas of focus:

• Construction of a production facility for hollow fibre dialysers, comprehensive and sustainable project management in process development, engineering, and procurement projects.
• Procurement and implementation of new production equipment and technologies. Technical support for quality management processes (change control, CAPA, design control).
• Design change.
• Monitoring of global patent activities. Execution of equipment qualification and process validation.
• Close collaboration with developers, marketing, suppliers, and regulatory authorities during development and design transfer to production.
• Primary and secondary packaging development.

2008 - 2014: Project management in research and development projects.

Role: Development Engineer, Scientific Researcher

Customer: BBraun Avitum Saxonia GmbH, Dpt. of Research and Development

Tasks:

• Participation in product and process development.
• Development of test equipment and methods for membrane characterization.
• Design Transfer of a new type of hollow fibre membrane to production.

Role: Project Manager

Customer: Pharmatec GmbH

Tasks:

• Project management for the creation of large scale customized production facilities in the Life Sciences sector.
• Preparation of proposals and specifications.
• Project execution until Site Acceptance Testing (SAT), including qualification.

2003 - 2007: Hollow Fiber Bioreactors

Role: Product Manager

Customer: Saxonia BioTec GmbH

Tasks:

• Comprehensive product management for disposable hollow fiber devices.
• Monitoring of production processes.
• Development of customized products.
• Product and process development for hollow fiber bioreactors and transition to production.
• Administrative tasks.
• Close collaboration with customers, research institutes and suppliers.

Role: Development Engineer

Customer: Quodata GmbH

Tasks:

• development of an automated ELISA method for detecting hormone-like substances in trace concentrations in water.

Role: Scientific Researcher

Customer: University of Technology Dresden, Chair of Chemical Engineering

Tasks:

• Analysis of qualification requirements in high technologies.

1999 - 2000: Chair of Waste Management and Contaminated Sites treatment

Role: Scholarship holder

Customer: University of Technology Dresden

Tasks:

• Investigations on the microbiological remediation potential of contaminated aquifers