Gene Therapy Bioprocess Senior Engineer (DS)

le contenu du travail

To strengthen our Gene Therapy (GT) CMC Bioprocess Engineering Team, based in Braine-l’Alleud (Belgium) we are looking for a talented individual to fill the position of: Gene Therapy Bioprocess Senior Engineer (DS).

The role involves definition of equipment and single-use assemblies user requirements as well as supporting design and qualification for all relevant clinical manufacturing steps with specific focus on DS process equipment. This will be performed in close collaboration with the engineering-, qualification - and quality assurance departments.

Furthermore, technology transfer to-and from the clinical GT manufacturing plant are in scope. This involves process evaluation for facility fit, scale-up and mass balances as well as creation and review of process documentation such as risk assessments, process descriptions, summary reports submission sections and tech transfer protocols.

Finally process validation and continued process verification activities are supported in collaboration with the process development team.

The successful candidate will be part of a team of process engineers supporting the establishment and operation of a clinical manufacturing plant for gene therapy products.

More precisely, as a Gene Therapy Bioprocess Senior Engineer (DS), your main responsibilities are:

• Process transfer from development to DS clinical/commercial manufacturing.
• Lead Gene Therapy Bioprocess Engineering input to facility and DS equipment design and qualification.
• Lead integration projects to ensure timely GMP readiness for clinical rAAV production.
• Design and qualify DS process equipment. Generation of risk assessments and user specifications for manufacturing systems and single-use materials.
• Lead 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 define robust and scalable processes and ensure seamless technology transfers.
• Roll out of raw materials and single-use equipment: risk assessments, specification setting and design of single use assemblies.
• Generation of relevant documentation such as Process Descriptions, SOPs and risk assessments to implement new processes to clinical manufacturing.
• 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.
• Lead continuous digitalization of the clinical manufacturing plant.
• Drive 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.
• 
  

Interested? For this position you’ll need the following education, experience and skills:

• Master’s Degree preferably in Bioengineering or related fields.
• At least 5 years of industrial experience, preferably in a GMP environment (chemical, pharmaceutical or biotech).
• Expert knowledge of Biologics Manufacturing, specifically of Drug Substance Manufacturing. rAAV Manufacturing and/or Process Development experience would be highly beneficial.
• Excellent Process Engineering skills including scale-up and knowledge of tech transfer principles.
• Experience with sterility concepts, bioburden reduction approaches, including systematic risk assessments and troubleshooting.
• Hands-on experience with mammalian cell culture- and/or purification systems in clinical or commercial GMP manufacturing.
• Experience in working with control system (DCS) e.g. PCS7 or DeltaV.
• Very good command in English, a good command in French is a strong asset.

Soft skills:

• Track-record of delivering project milestones within tight timelines.
• Ability to prioritize project work and make effective use of available resource.
• Ability to align stakeholders and drive decision making processes.
• Strong interpersonal skills to communicate and maintain good working relationship with internal and external stakeholders.
• Strong problem-solving skills for process issues related to manufacturing process or to facility design.

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.