Bioprocess Engineer (Single Use Technology)

Contenuto del lavoro

Make your mark for patients

We are looking for a Bioprocess Engineer (Single Use Technology) to join us in our Bioprocess Engineering team within our Clinical Manufacturing Sciences for Biologics and Gene Therapy department, based in Braine-l’Alleud, Belgium.

About The Role

• Definition of processing equipment and single-use (SU) assemblies user requirements as well as design and qualification for all relevant clinical manufacturing steps with specific focus on SU manufacturing components.
• Establishment and maintenance of the SU library of all assemblies and components used for upstream, downstream and drug product manufacturing. This includes the establishment of design requirements based on manufacturing process and operational needs as well as quality and regulatory requirements.

Who You’ll Work With

• Guillaume Le Reverend as your Manager. Furthermore, you will be part of a team of Bioprocess Engineers supporting the establishment and operation of UCB Clinical Manufacturing Plants for monoclonal antibody (mAb) and recombinant adeno associated virus (rAAV) products.

What You’ll Do

• Act as the Bioprocess Engineer / Subject Matter Expert on SU technologies and, as such, establish close collaboration with suppliers and internal stakeholders (Engineering, Operations, Process Development, Quality, Regulatory, Devices and Primary Packaging).
• Scout for and evaluate new SU technologies.
• Lead selection, design and qualification of SU Bioprocess containers, liquid transfer assemblies and sensors as well as processing aids (e.g. filters and SU chromatography columns) for mAb and rAAV clinical manufacturing plants.
• Establish all relevant SU related risk assessments (e.g. system closure, SU integrity, support of materials of contact (MoC) assessment).
• Lead SU material integration to ensure timely GMP readiness for clinical production in line with UCB standards and procedures.
• Generate relevant documentation such as Process Descriptions and SOPs to implement new processes to clinical manufacturing.
• Support SU change management.
• Support design and qualification of Drug Substance and Drug Product process equipment.
• Develop and execute a supply risk mitigation plan in collaboration with procurement (dual sourcing strategy and material supply agreements).
• Closely collaborate with process development and clinical manufacturing to define robust and scalable processes and ensure seamless technology transfers.
• Support establishment of appropriate data management systems for knowledge management and campaign reports.
• Support of regulatory filings and application of Quality-by-Design (QbD) principles.
• Support continuous digitalization of the clinical manufacturing plants.
• Drive continuous process optimization, implementation of new technologies and operational improvements in close collaboration with operations.
• Support root-cause investigations, change controls, CAPA plan implementations in close collaboration with the QA department.

Interested? For this role we’re looking for the following education, experience and skills

• Master’s degree preferred in a related field.
• At least 5 years of industrial experience, preferably in a GMP environment (Chemical, Pharmaceutical or Biotechnology), working with mAb and/or rAAV is a plus.
• Extensive experience of SU biomanufacturing systems and suppliers.
• Hands-on experience with :
• Cell culture, purification and drug product systems in clinical or commercial GMP manufacturing.
• Sterility concepts, bioburden reduction approaches, including systematic risk assessments and troubleshooting.
• Experience in Project Management, delivering milestones within tight timelines.
• Very good command in English, French is a plus or having the willingness to learn French.
• 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.
• Ability to align stakeholders and drive decision making processes.
• Ability to prioritize project work and make effective use of available resource.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

Learn more about sustainability at UCB and how it is integrated into our business approach.

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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.