uDiscover Program (VIE) - Gene Therapy Bioprocess Engineer

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 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 interface between process development and DS clinical manufacturing
• 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.
• Support transfer of new processes and technologies to-and from clinical manufacturing while ensuring operational excellence and cGMP compliance.
• Closely collaborate with process development and (clinical) manufacturing to ensure seamless technology transfers.
• Support roll out of raw materials and single-use assemblies.
• Generation of relevant documentation such as Process Descriptions, SOPs and risk assessments to implement new processes to clinical manufacturing.
• If required, support design/generation of DS manufacturing recipes in distributed control system.
• 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

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.
• Hand-on experience with mammalian cell culture- and/or purification systems.
• Familiarity with distributed control system (DCS), specifically PCS7, is highly beneficial.
• Knowledge/Experience of/in sterility concepts, bioburden reduction approaches, including systematic troubleshooting.
• Prioritization and time management skills.
• Industrial experience (chemical, pharmaceutical or biotech) with equipment and facilities of pilot scale or higher highly beneficial.
• Excellent engineering skills including scale-up.
• 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

About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.