Make your mark for patients
We are looking for a Bio Drug Substance Validation Engineer who is detail-oriented, proactive, and collaborative to join our team in our campus based in our office in Braine-l'Alleud, Belgium.
About the Role
As a Bio DS Validation Engineer, you will ensure the validation of manufacturing processes for biological products (culture, purification, media preparation) in compliance with cGMP, HSE regulations, and the Site's Validation Master Plan (SVMP). You will also validate associated processes such as cleaning and sterilization of equipment, ensuring the qualified state of equipment and systems.
Who You Will Work With
You will work closely with internal clients, internal support services (IT, Metrology, Periodic Control, Users,…), internal experts (cleaning validation and CSV,…), and external suppliers. You will also interact with the Quality Assurance Department to ensure compliance with current regulations, guidelines, standards, and internal procedures (SOP).
What You Will Do
* You act as the SME for Qualification/Validation in the context of new systems and processes including CSV aspects.
* You define, propose and coordinate the qualification/validation strategy for systems and equipment.
* You perform and facilitate quality risk analyses.
* You draft the validation plan and associated documents.
* You coordinate and monitor qualification/validation activities/large scale projects.
* You develop partnerships with internal clients and support services.
* You participate in internal audits, external audits, and regulatory inspections.
* You report any issues impacting the quality of systems, instruments, or products.
* You ensure compliance with current legislation and HSE rules.
Interested? For this role, we are looking for the following education, experience, and skills
* Master's degree in a scientific field.
* Minimum 10 years of experience in validation (cleaning validation, sterilization, environmental monitoring, periodic review).
* Ability to work in a highly dynamic environment and handle challenging situations.
* High communication skills (leadership, negotiation, change management, facilitation).
* Decision-making ability and high sense of responsibility.
* Fluent in English; fluency in French is highly recommended.
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 EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.