Qualification and Validation Lead

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

• Define and represent qualification and validation requirements across the project.
• Ensure compliance with regulatory and quality standards throughout design and delivery.
• Review and assess technical documentation related to validation activities.
• Contribute to inspection readiness and support audit and regulatory interactions.
• Translate operational and regulatory expectations into project requirements.
• Promote strong quality and compliance culture across stakeholders.

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

• Experience in qualification and validation within regulated environments.
• Knowledge of GMP requirements and regulatory expectations.
• Experience supporting audits and regulatory inspections.
• Strong ability to analyse and interpret technical documentation.
• Strong communication and collaboration skills.
• Willingness to adapt to project variabilities and a rapidly evolving work environment.
• Fluent in English; French is an advantage.
• 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!