Validation Specialist

Make your mark for patients

We are looking for a Validation Specialist who is eager to join our Internal Manufacturing department, based on our production site in Bulle, Switzerland.

About the role

As Validation Specialist, you will ensure the validation of manufacturing and cleaning processes is in line with procedures, regulatory requirements, and user needs. You will ensure adherence to the site Validation Master Plan and cleaning verification plan, provide expertise in validation and manufacturing processes during investigations, change controls, and projects, and present validation/verification/CPV documentation during inspections and audits.

Who you’ll work with

You will collaborate with manufacturing teams, internal and external laboratories, the Analytical Validation team, and cross-functional project groups. You will also interact with health authorities and partners during audits and inspections.

What you’ll do

• Support and/or coordinate process and cleaning validation/verification activities, including defining validation strategies.
• Drive and write validation risk assessments, change-over protocols, and change controls for current and new processes.
• Write validation plans, protocols, and reports in adherence with planning.
• Coordinate sampling and analyses with manufacturing teams and laboratories.
• Lead the implementation and ensure compliance of Continued Process Verification (CPV) for current and new processes.
• Participate in continuous improvement of validation documentation and processes.
• Lead validation-related projects and participate in technical or organizational cross-functional projects.
• Work according to cGMP requirements; ensure all training is up to date.
• Participate in deviations and change controls as SME for validation/CPV/verification-related subjects.
• Ensure all validation/CPV/verification documentation is up-to-date and inspection ready.
• Actively promote and respect HSE policy and processes.
• Integrate UCB’s ambitions for diversity, equity, inclusion, business health management, environmental policy, ethics, compliance, and patient value culture into daily responsibilities.

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

• Bachelor’s, Master’s, or Ph.D. in a relevant technical field.
• High understanding of biotechnological manufacturing processes.
• Ability to scope, research, and understand complex subjects related to biotech manufacturing.
• Ability to structure ideas quickly and clearly.
• Excellent organization and problem-solving skills.
• Strong leadership skills.
• Good proficiency with MS Office tools.
• Basic knowledge of statistics.
• Excellent communication skills for internal and external partners.
• Ability to define objectives and how to reach them.
• High capacity to anticipate issues, identify priorities, and make decisions.
• High level of autonomy and good stress management skills.
• Solution-oriented and sensitive to customer needs.
• Pragmatic and critical-minded.
• Sense of responsibility, ownership, and initiative.
• Team player.
• High level of spoken and written French and English.

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 E-Mail schreiben. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.