Specialist Data Integrity / CSV

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob FunctionQualityJob Sub FunctionQuality ControlJob CategoryProfessionalAll Job Posting Locations:Schaffhausen, SwitzerlandJob DescriptionJob Title: Specialist Data Integrity / CSV (80-100%)Location: Schaffhausen, Switzerland | Flexible start dateAt Johnson & Johnson, health is at the heart of everything we do. Leveraging our strength in healthcare innovation, we empower a world where diseases are prevented, treated, and even cured. At Cilag AG, part of Johnson & Johnson’s Janssen Pharmaceutical division, we produce pharmaceutical products, medical devices, and active pharmaceutical ingredients (APIs) for global markets.We are seeking a passionate Specialist, Data Integrity / CSV to champion the lifecycle management of laboratory equipment, enhance data governance practices, and contribute to lab automation. Join our Site Quality Control team in Schaffhausen and make a difference in patients' lives globally.Key ResponsibilitiesLaboratory Equipment & Software Qualification:Plan and execute qualification activities (in line with GMP and regulatory standards)Author qualification lifecycle documents (e.g., URS, IOPQ protocols)Support the revision of procedures (WIs, SOPs) related to data integrity and equipment lifecycle managementPerform installation, configuration, testing, and troubleshooting on laboratory systemsData Integrity & GovernanceDefine requirements for new software solutions and analyze data/process flowsArchive or migrate legacy system dataSupport the investigation into data integrity issues and software non-conformities (CAPA)Cross-functional CollaborationWork with internal teams (Quality Control, R&D, IT) to ensure seamless integration of laboratory systems and data workflows.Collaborate effectively with external vendors for technical support, including manufacturer qualifications, maintenance, troubleshooting, and investigations.QualificationsEducation:M.Sc. / B.Sc. in Natural Sciences, Computer Science, Engineering, or related field (Alternatively: Comparable training with several years of relevant experience)Required Skills & ExperienceProven work experience in GMP-regulated environments (preferably Quality Control)Strong analytical and problem-solving skillsExperience drafting qualification documents (clear, concise, accurate)Fluent in English and basic spoken German skills (B1 or above desirable)Preferred Skills & Technologies (advantageous But Not Required)Hands-on familiarity with laboratory equipment qualificationExperience with SAP, TrackWise, or TruVaultExperience with virtualization (e.g., VMware, Virtual Box)What We OfferOpportunities to shape laboratory innovation in a global company at the forefront of healthcareAccessible location in beautiful SchaffhausenCollaborative, inclusive work environment that values work-life balance