Make your mark for patients
We are looking for a Qualification and Validation Lead who is collaborative, rigorous and proactive to join us in our BioNexUS Internal Manufacturing team, based in our UCB campus in Bulle, Switzerland.
About the role
This role is part of the BioNexUS project, contributing to the design and delivery of a future-ready biologics manufacturing facility. You will ensure that manufacturing systems, equipment and processes are designed and delivered in compliance with regulatory and quality requirements. You will contribute to building a compliant and inspection-ready facility by integrating validation principles throughout the project lifecycle in a rapidly evolving project environment.
Who you’ll work with
You will be working in a team that collaborates with manufacturing sites, quality experts and project stakeholders. The team focuses on ensuring compliance, alignment with regulatory expectations and readiness for inspections working across different time zones.
What you’ll do
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Define and represent qualification and validation requirements across the project.
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Ensure compliance with regulatory and quality standards throughout design and delivery.
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Review and assess technical documentation related to validation activities.
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Contribute to inspection readiness and support audit and regulatory interactions.
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Translate operational and regulatory expectations into project requirements.
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Promote strong quality and compliance culture across stakeholders.
Interested? For this role we’re looking for the following education, experience and skills
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Experience in qualification and validation within regulated environments.
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Knowledge of GMP requirements and regulatory expectations.
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Experience supporting audits and regulatory inspections.
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Strong ability to analyse and interpret technical documentation.
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Strong communication and collaboration skills.
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Willingness to adapt to project variabilities and a rapidly evolving work environment.
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Fluent in English; French is an advantage.
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Regular travel to Belgium and occasional travel to the United States may be required during conceptual design and basic design phases.
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 over 9.000 people in all four corners of the globe, inspired by patients and driven by science.
Why work with 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 equal 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.
At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
