We are currently looking for a Project Manager Tech Transfer, for a long term project at our client in the area of Ghent. As a Project Manager Tech Transfer, you will execute a new investment project, during which you will be responsible for the technology transfer and the set-up of a new production unit and facility-upgrade.
The production unit will consist of bulk preparation, filling and labelling, printing, (barcode)scanning, packaging,… in a GMP-environment (clean room ) and requires:
- Technology, design and process transfer from US based company.
- Manage the engineering project within the defined timelines, budget and quality
- Define and document the required validation approach
- Execute hands-on work resulting in approved validation documents and in execution of validation activities
- Process design and documentation (personnel and material flow diagrams, FMEA) , based on the technology transfer, taking into account current facility design and existing processes (for filling process, clean room specifications, QC- and IPC-definition, ( intermediate) storage,… ), leading to a finally validated process (process qualification and validation)
- Equipment specifications, based on existing machines on other locations, followed by the full purchase, design and development project up to a validated equipment ( SR ( URS ), Risk analysis, IQ, OQ, performance qualification )
- Development of facility specifications, and an upgrade of the existing facility according to defined process-flow and process-requirements