Opportunity open to freelance or temporary employed consultant. Make your mark for patients We are looking for a Senior Validation Engineer (Performance Qualification) who is experienced, meticulous, and collaborative to join us as a contractor in our Genesis team, based in our campus site of Braine l’Alleud. About the Role As a Senior Validation Engineer (PQ Phase) contractor for UCB, you will drive the preparation and execution activities of the Performance Qualification (PQ) phase of the project, ensuring they are completed in accordance with system requirements, specifications, quality attributes, and project procedures/guidelines. You will act as the C&Q Subject Matter Expert and Compliance for PQ, providing guidance and working with project stakeholders and suppliers. Who You Will Work With You will collaborate with a dynamic team within the Local Sites Engineering department. Together, you will work closely with technical, QA, validation, and QC teams, as well as suppliers, to ensure the successful completion of PQ activities. You will also interact with various stakeholders to meet cGMP and quality requirements on time and on budget. What You Will Do You develop PQ strategy/protocols and testing rationales following approved PQ VMP. You coordinate review and approval cycles in a timely manner. You assist in the development of specific Quality Risk Assessments for PQ. You drive PQ verification deliverables, cycle development, protocol execution, and deviation investigation. You plan, track, and report C&Q status and risks/issues for selected systems. You establish and monitor validation KPIs. You review handover of equipment/systems from suppliers and other project stakeholders. Interested? For this role, we are looking for the following education, experience, and skills Bachelor's or Master's degree in Engineering or a related field. Minimum 5 years of hands-on experience with PQ phase, including sterile manufacturing. Strong understanding of risk-based commissioning and qualification within biotechnology. Experience with ISPE best practices, GAMP-5, Annex 15 GMP EU, ASTM E2500. Excellent knowledge of applied statistics, quality systems, and regulatory requirements. Proven project management experience in a cross-functional environment. Fluent in English; knowledge of French is a plus. #genetherapy 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 UCB UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with UCB? 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 equitable 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. UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity. Employment or engagement If you have been selected to work for UCB, please note that you will be formally employed by a staffing agency (in case of being a temporary employed consultant) or engaged via a broker (in case of being a freelancer), to work for UCB. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.