uDiscover Program (VIE) - Gene Therapy Bioprocess Systems Engineer

仕事内容

UCB France cherchant à développer son pôle biopharmaceutique en Belgique a besoin de ressources humaines aux compétences spécifiques afin de gérer depuis ce pôle la production de ses produits actifs dans le traitement des maladies auto-immunes.

UCB France cherche dès lors à renforcer les compétences locales par des ressources en VIE (Volontariat International en Entreprise) dans un but de maîtrise et d’optimisation de la compétitivité de ses productions distribuées à l’échelle mondiale.

Le site de Braine l’Alleud est spécialisé dans la synthèse chimique, le développement, la fabrication et le conditionnement de produits pharmaceutiques.

As a VIE Bioprocess Systems Engineerwithin the Biotech Sciences department, you will directly report to Head of Gene Therapy Bioprocess Engineering. You will be part of a team of process engineers supporting the establishment and operation of a clinical manufacturing plant for gene therapy products.

Your missions:

• Act as Gene Therapy Bioprocess Engineering SME for facility and equipment design and qualification
• Support design and qualification of DS process equipment.:
• Generation of Risk assessments and user specifications for manufacturing systems and single-use materials.
• Design verification
• FAT and SAT
• IQ/OQ
• Media batches
• Support transfer of new processes and technologies while ensuring operational excellence and cGMP compliance.
• Closely collaborate with maintenance and metrology for lifecycle management of equipment.
• Generation of relevant documentation such as Process Descriptions, SOPs and risk assessments to implement new processes to clinical manufacturing.
• Floor support
• Trending and analysis of manufacturing data and generation of campaign reports. Support establishment of appropriate data management systems for knowledge management.
• Support of regulatory filings and application of Quality-by Design (QbD) principles
• Support continuous digitalization of the clinical manufacturing plant.
• Support continuous process optimization, implementation of new technologies and operational improvements in close collaboration with process development
• Support root-cause investigations, change controls, CAPA plan implementations in close collaboration with the QA department
• Author and review comprehensive and accurate technology and manufacturing documentation, procedures, specifications and protocols/reports.

Your profile:

• Master’s degree in Engineering/Sciences (chemistry, biotech, sciences)
• Good technical knowledge of biologics manufacturing, specifically of the DS manufacturing (upstream-and downstream). AAV manufacturing and/or process development experience would be highly beneficial.
• Familiarity with distributed control system (DCS), specifically PCS7, is highly beneficial.
• Hand-on experience with mammalian cell culture- and/or purification systems.
• Knowledge/Experience of/in sterility concepts, bioburden reduction approaches, including systematic troubleshooting.
• Good knowledge of equipment qualification principles and ASTM E2500
• Prioritization and time management skills.
• Industrial experience (chemical, pharmaceutical or biotech) with equipment and facilities of pilot scale or higher highly beneficial.
• Project management skills would be highly beneficial.
• Interpersonal skills to communicate and maintain good working relationship with internal costumers and external contacts/costumers.
• Fluent in French and English
• Ability solve problems for process issues related to manufacturing process or to facility design.
• Ability to prioritize project work and make effective use of available resource.
• Ability to apply learning to other projects/situations.

Please note that to be eligible to the Belgium VIE program, you need to :

• Be between age 18 and 28
• Hold nationality of one of the European Union country
• Have not worked or lived in Belgium for at least a year