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Project Manager Tech Transfer

Pauwels Consulting | Zwijnaarde | Onbepaalde duur, Zelfstandige, Voltijds

Pauwels Consulting is een Belgisch consultancy kantoor met meer dan 520 experts op het gebied van engineering, life sciences en IT. Wij helpen vooraanstaande bedrijven in België en het buitenland met consulting, project management en werving en selectie. We hebben kantoren in België, Frankrijk, Duitsland en Zwitserland (https://www.pauwelsconsulting.com/nl/over-ons/contact/) .

Project Manager Tech Transfer

Functieomschrijving

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

  • 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

  • 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
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Kenmerken

Vereisten

  • Master (Licentiaat; Universiteit of Hoger Onderwijs Lange Type)

Aanbod

  • Onbepaalde duur
  • Zelfstandige
  • Voltijds
  • Bedrijfswagen

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