Qualification and Validation Lead

pbMake your mark for patients /b /ppWe are looking for a bQualification and Validation Lead /b who is collaborative, rigorous and proactive to join us in our bBioNexUS Internal Manufacturing team /b, based in our bUCB campus /b in bBulle, Switzerland. /b /ppbAbout the role /b /ppThis 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. /ppbWho you’ll work with /b /ppYou 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. /ppbWhat you’ll do /b /pliDefine and represent qualification and validation requirements across the project. /liliEnsure compliance with regulatory and quality standards throughout design and delivery. /liliReview and assess technical documentation related to validation activities. /liliContribute to inspection readiness and support audit and regulatory interactions. /liliTranslate operational and regulatory expectations into project requirements. /liliPromote strong quality and compliance culture across stakeholders. /lipbInterested? For this role we’re looking for the following education, experience and skills /b /pliExperience in qualification and validation within regulated environments. /liliKnowledge of GMP requirements and regulatory expectations. /liliExperience supporting audits and regulatory inspections. /liliStrong ability to analyse and interpret technical documentation. /liliStrong communication and collaboration skills. /liliWillingness to adapt to project variabilities and a rapidly evolving work environment. /liliFluent in English; French is an advantage. /liliRegular travel to Belgium and occasional travel to the United States may be required during conceptual design and basic design phases. /lipAre 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! /p