Industrialization & Process Validation & Tech Transfer Expert (m/f/d)

仕事内容

Thermo Fisher Scientific Inc. est le leader mondial au service de la science, avec des revenus annuels dépassant 30 milliards de dollars. Notre mission est de permettre à nos clients de rendre le monde plus sain, plus propre et plus sûr. Que nos clients accélèrent la recherche en sciences de la vie, résolvent des défis analytiques complexes, améliorent les diagnostics et les thérapies des patients ou augmentent la productivité dans leurs laboratoires, nous sommes là pour les soutenir. Notre équipe mondiale de plus de 80000 collègues offre une combinaison inégalée de technologies innovantes, d’achat de commodités et de services pharmaceutiques par le biais de nos marques leaders de l’industrie, notamment Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services et Patheon.

En tant que l’une des plus grandes entreprises de biotechnologie en Belgique, nous fournissons des services aux industries des sciences de la vie avec des technologies spécialisées. HENOGEN, qui fait désormais partie de Thermo Fisher Scientific, est basé à Seneffe et Gosselies, où travaillent environ 400 des 80 000 employés de l’entreprise dans le monde.

Lorsque vous faites partie de l’équipe de Thermo Fisher Scientific, vous effectuez un travail significatif, qui a un impact positif à l’échelle mondiale. Rejoignez 80 000 de nos collègues qui donnent vie à notre mission chaque jour pour permettre à nos clients de rendre le monde plus sain, plus propre et plus sûr. Vous trouverez ici les ressources nécessaires pour atteindre vos objectifs de carrière et vous aider à faire progresser la science en développant des solutions pour certains des défis les plus difficiles au monde, comme la protection de l’environnement, la sécurité alimentaire ou la recherche de remèdes contre le cancer.

Industrialization & Process Validation & Tech Transfer Expert (m/f/d)

Region Belgium – Gosselies

The Industrialization Process Validation and Technology Transfert expert acts to develop the image and the notoriety of HENOGEN with the ambition to position the company as key player and a reference in provision of service for the commercial production of Biotechnology products.

Responsabilités Principales

• Technology Transfer implementation
• Define the objectives and set up the Technology Transfer plan with the external partners and with the other departments of HENOGEN.
• Implement the Technology Transfer plan and coordinate the activities of the concerned departments to ensure that the timelines are respected.
• Gather and write the documents required to support and to close the Technology Transfer.
• Support the receiving units in the practical implementation of the activities linked to the Dry runs, Wet runs and Engineering runs.
• Acquire, from the sending units, the practical knowledge and competencies specific to the processes and take part in their transfer to the receiving units.
• Process validation stage II and III implementation
• Identify and challenge process validation needs with the client, R&D, commercial production and the QA/RA.
• Set up the validation studies to support the Process Validation: hold times, stability, cleaning, bacterial challenge test, media fill test, container integrity test, mixing and homogeneity, ...
• Perform risk assessments: extractible & leachable, adventitious agent, …
• Set up the final control strategy.
• Ensure readiness for Process Performance Qualification and make sure that validations, protocols and procedures are executed in agreement with regulatory requirements.
• Support the commercial unit for the implementation of the Process Performance Qualification campaign.
• Set up the Continued Process Verification strategy.

• Process development follow up
• Follow the setup of the upstream process development strategy and of the Process Characterization plan by the PPD to ensure that the decisions taken are compliant with the industrialization vision and the commercial expectations.
• Make sure that all requirements needed to support the Process Validation and the Technology Transfer are met.
• Support for investigation
• Support the clinical and commercial production department to address major deviations
• Set up and lead trouble shooting to solve major performance issues in clinical and commercial production.
• Documentation
• Generate documents to support the Technology Transfer and the Process Validation : TT plan protocols, procedure, process flow diagrams, reports …
• Provide and update the project transfer planning and the action lists.
• Reporting
• Define the key performance indicators and keep them updated.
• Perform a weekly reporting about the projects.
• Perform the monthly reporting about the projects.
• Operational Excellence
• Make proposals to improve the structure and the organization.
• Perform periodically inspections on the shopfloor.
• Define the key performance indicators.
• Prepare and lead the AICs
• Implement and support the 5S methodology in the teams.
• Safety
• Respect and insure that current safety and biosafety regulations are respected by the teams.

• Quality
• Guaranty the document quality.
• Respect the quality system put in place in HENOGEN Belgium.

Profil:

• Academic training at least Master in Biology or similar fields.
• Technical knowledge in protein and viral vectors production and analytical methods.
• Project coordination paired with presentation skills (verbal and written).
• Suite MS Office (Excel, word, powerpoint) and social network.
• Fluent in English & French is a prerequisite (spoken and written).
  

Chez Thermo Fisher Scientific, chacun de nos 80 000 esprits exceptionnels a une histoire unique à raconter. Rejoignez-nous et contribuez à notre mission unique: aider nos clients à rendre le monde plus sain, plus propre et plus sûr. Postulez dès aujourd’hui sur http://jobs.thermofisher.com.