Bio Process Subject Matter Expert
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Make your mark for patients
We are looking for a Bio Process Subject Matter Expert (SME) who is strategic, collaborative, and solution-oriented to join our Global Engineering and Biopharmaceutical Development team, based at our UCB campus located in Braine-l’Alleud, Walloon Brabant, Belgium.
About the role
As a Bio Process SME, you will be at the heart of our global engineering and biopharmaceutical development ecosystem. You will help shape the technical vision and lifecycle strategy for biopharmaceutical processes, from development to industrial-scale manufacturing. You will ensure our process solutions are robust, scalable, compliant, and future-ready across development, scale-up, technology transfer, and commercial production.
Who you will work with
You will work closely with Engineering, MSAT, Process Development, Operations, Quality, Validation, and external partners. You will act as a strategic technical partner across sites and projects, helping teams align process requirements with engineering design, compliance expectations, and manufacturing needs. You will also contribute to knowledge sharing, standardization, and the adoption of new technologies.
What you will do
• You will define process strategies, standards, and best practices for USP, DSP, filtration, viral clearance, CIP and SIP.
• You will support CAPEX projects from feasibility through commissioning, qualification, and process performance qualification.
• You will translate process needs into URS, design inputs, PFDs, mass balances, and critical process parameters.
• You will lead or support process scale-up, industrialization, and technology transfers across sites or external partners.
• You will ensure alignment with GxP, GMP, FDA, EMA, validation, and quality-by-design expectations.
• You will analyze process performance, support troubleshooting, and drive continuous improvement in robustness, yield, and efficiency.
Interested? For this role, we are looking for the following education, experience, and skills:
• You have a degree in Biotechnology, Biochemical Engineering, Chemical Engineering, or an equivalent scientific field.
• You bring significant experience in biopharmaceutical process development, manufacturing, scale-up, or industrialization.
• You have strong expertise in USP and/or DSP processes and bio-process equipment.
• You understand GMP, GxP, qualification, validation, PPQ, CPV, and process robustness principles.
• You are confident using data analysis, process modeling, statistical tools, and risk assessment methods.
• You communicate clearly, influence across functions, and turn complex technical topics into pragmatic solutions.
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
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