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.com **Job Function:** Quality **Job Sub** **Function:** Quality Control **Job Category:** Professional **All Job Posting Locations:** CH008 Cilag AG, Schaffhausen **Job Description:** **Senior Specialist Data Integrity / CSV (80-100%)** 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.com Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. **Learn more at https://www.jnj.com/innovative-medicine** We are seeking a passionate **Senior 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 Responsibilities:** + **Laboratory Equipment & Software Qualification:** + Plan and coordinate qualification activities (in line with GMP and regulatory standards) + Author comprehensive qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, IOPQ protocols) + Authoring and review of procedures (WIs, SOPs) related to data integrity and equipment lifecycle management + Perform installation, configuration, testing, and troubleshooting on laboratory systems + **Data Integrity & Governance:** + Define requirements for new software solutions and analyze data/process flows + Develop and oversee security, backup, and recovery strategies for laboratory systems (e.g., databases) + Archive or migrate legacy system data + Investigate data integrity issues and software non-conformities (CAPA) + **Cross-functional Collaboration:** + Act as a bridge between 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. + Provide training and guidance to end-users, fostering cross-functional understanding of laboratory systems and automation processes. + Lead initiatives to improve interaction between teams by streamlining communication on project requirements, system upgrades, and troubleshooting efforts. **Qualifications:** **Education:** + Ph.D. or M.Sc. in Natural Sciences, Computer Science, Engineering, or related field + (Alternatively: Bachelor’s degree with several years of relevant experience in a GMP setting) **Required Skills & Experience:** + Proven work experience in GMP-regulated environments (preferably Quality Control) + Strong analytical and problem-solving skills + Experience 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 qualification, CSV, databases, or virtualization (e.g., VMware) + Experience with SAP, TrackWise, or TruVault + Ability to convey technical material to non-specialists **What We Offer:** + Opportunities to shape laboratory innovation in a global company at the forefront of healthcare + Accessible location in beautiful Schaffhausen + Collaborative, inclusive work environment that values work-life balance