Verantwoordelijkheden van de Project Manager Tech Transfer
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
Profiel van de Project Manager Tech Transfer
- Proven experience in project management (+ 5 years ) in a GxP environment (pharmaceutical / life-sciences ) and related documentation. Preferably experience in Medical Devices.
- Knowledge of risk-based assessments (technical – GxP ) for requirement-setting and required testing/validation
- Experienced in tech transfer and process design and -development or at least having back-up knowledge in the own organisation
- Commissioning and validation-knowledge for manufacturing equipment (including writing and execution of validation-documentation)
- Experienced with specifications (setting) for manufacturing processes, equipment and clean room facilities.
- Have full understanding of goals and different aspects of equipment and process qualification and validation within a GxP- environment (including e.g. definition of process targets, specification-limits and control-limits)
- Fluent in Dutch and English, both oral and written.
- Good written and oral communication (from floor to international contacts)
- an open-minded, proactive and accurate mindset and strong negotiation skills
Aanbod voor de Project Manager Tech Transfer
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees