Senior Medical Consultant

8/2023 – 1/2024

Gap analysis of sterile barrier system
Prepare the sterile barrier system bench testing plan: including extreme
environmental conditioning, shipment simulation, packaging and functional tests
Define the necessary unique distribution cycle (DC 2 according to ASTM D4169)
proper for the planned logistics
Define climate conditioning parameters depending on target market
Create sterile packaging standard implementations and summary document
Coordinate the bench testing process.
Define the packaging test methods and create test descriptions

DIN EN ISO 13485, Prozessvalidierung, Verpackungsdesign

2/2022 – 9/2023

Gap analysis for sterilisation and sterile packaging
Coordinate the sterile barrier system developments
Risk analysis of the sterilisation and sterile barrier system
Define the sterilisation strategy of new products
Prepare the sterilisation and sterile packaging process validation plan
Prepare the sterilisation and sterile packaging Design Verification plan
Create sterile packaging standard implementations and summary document
Coordinate sterilisation and sterile packaging validation and verification
Define the packaging test methods and create test descriptions
2
Define the proper machines and tools for packaging tests
Calculate the EO residual limits after sterilisation for new products
Define microbiological limits (CFU limits) for new products
Define endotoxin test frequency and limits
Define physical contamination test frequency and limits

Ingenieurwissenschaft, DIN EN ISO 13485, Verpackungsdesign

10/2020 – 2/2022

Coordinate the daily work of the engineering and maintenance team (10 employees)
Ensure continuous production
Improve manufacturing process, implement LEAN concepts
Validation of new processes and equipment
NPI – transfer newly developed products/machines into the production

DIN EN ISO 13485, Verpackungstechnik, Management (allg.)