Cleaning Validation Expert (m/f/d)

ppWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. /p pUnited As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. /p pAs a member of the “Cleaning Validation” group within the Manufacturing Sciences and Technologies (MSAT) team, you will be involved in activities related to the validation of Biotechnological cleaning processes (Drug Substance and Drug Product). /p pThe cleaning process validation activity is performed in collaboration with various site teams (Production, Quality, Engineering, …) and covers the definition of cleaning validation strategies, monitoring of validation runs, data compilation, analysis of results obtained, investigations, and drafting of validation documentation. It also includes monitoring of cleaning processes and, if needed, the development of cleaning processes. /p h3Your Role /h3 ul liDefine validation strategies, in collaboration with the project lead and other site departments, for New Product Introductions (NPIs), Technology Transfer (TT), cleaning process validations, or changes affecting commercial products. /li liBring the required level of expertise to the project team by identifying risks, potential optimizations, the most relevant technical choices, and operational constraints. /li liDevelop cleaning processes as needed to ensure proper execution of the validation. /li liCoordinate on-site cleaning validations in collaboration with the affected departments. /li liEnsure timely preparation of required documents (plans, protocols, and reports, risk analyses, etc.) as defined in the project plan. /li liTrain production teams on validation protocols. /li liSupervise and support the execution of validation protocols, including outside standard working hours if necessary. /li liEnsure proper documentation and data management using the relevant information systems, including quality management software. /li liCompile data / collect data from production. /li liInterpret the results obtained within the framework of cleaning process validation trials. /li liManage deviations and validation investigations in the appropriate system. /li liManage the monitoring of cleaning processes (drafting forms, planning, execution, drafting reports). /li liKeep validation procedures and standards up to date and optimize them according to requirements and evolving current standards. /li liActively participate in a culture of integrity and professional ethics. /li liEnsure compliance with legal and regulatory requirements and company directives. /li /ul h3Your Profile /h3 ul liMaster of Science in Biotechnology / Life Sciences / (Bio)Chemistry or equivalent degree, or at least 5 years of professional experience in biotechnology /li liDemonstrated experience in Cleaning validation. /li liStrong analytical and synthesis capabilities /li liExcellent writing skills /li liProficiency with GMP/GDP and good knowledge of health authority requirements /li liOrganized, persistent, and resilient /li liCollaborative mindset and ability to work well in a team, plus the ability to work independently and autonomously /li liVery good communication skills /li liAptitude for digital tools /li liFluent in French and English (spoken and written) /li /ul h3What we offer: /h3 pWe are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! /p pApply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity! /p /p #J-18808-Ljbffr