Bio Drug Substance Validation Engineer

Bio Drug Substance Validation Engineer

UCB - Union Chimique Belge

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.

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.