Qualification and Validation Lead
La Gruyère - Switzerland
Job Summary
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 youll 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 youll 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 were 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!
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 dont just complete tasks we create value. We arent 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 thats 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 weve 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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
About Company
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We're here because we want to transform patients’ lives by pushing the boundaries of what is possible.To achieve our ambition, we w ... View more