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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Schaffhausen, Switzerland Job Description: About Innovative Medicine 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for a passionate individual to join our Quality Control team us as a Specialist - Data Integrity / CSV (80-100%) in Schaffhausen , Switzerland. Purpose: You will take responsibility for laboratory computerized systems and analytical software used in regulated laboratory operations. This covers Windows endpoints, application servers, validated analytical software, user access controls, system documentation, and related lifecycle activities Acting as a key interface between Quality Control, Quality Assurance, IT, vendors, and laboratory users you will ensure that our computerized laboratory systems remain compliant, reliable, future-ready and fit for GMP use throughout their lifecycle. You will be responsible for: Laboratory Computerized Systems Lifecycle: Ensure timely and cost-effective execution of software qualification, validation, and lifecycle activities for GMP-relevant laboratory computerized systems. Coordinate software qualification, validation, administration, and lifecycle activities for laboratory systems in collaboration with business departments, Quality Assurance, global and local IT, vendors, and other relevant stakeholders. Create, maintain, and update SOPs and work instructions within the assigned area of responsibility. Projects, Infrastructure & Technical Support: Support and execute cross-functional projects related to laboratory equipment qualification, analytical software implementation, Windows lifecycle activities, system upgrades, and infrastructure changes. Provide technical support and troubleshooting for laboratory IT incidents, analytical software issues, Windows-related problems, vendor support activities, and business continuity topics affecting GMP laboratory operations. Compliance, Controls & Non-Conformances: Ensure compliance with applicable GMP, EHS, SOX, and internal procedural requirements associated with the role. Support and manage non-conformances, including technical assessment, documentation, impact or risk evaluation, and implementation of preventive and corrective actions (CAPAs). Qualifications / Requirements: Ph.D., Master’s degree, or comparable qualification in natural sciences, computer science, engineering, or a related field; equivalent practical experience in a GMP laboratory, CSV, laboratory IT, or data integrity environment may also be considered.   Relevant experience in at least one of the following areas: laboratory equipment qualification and software validation within a GMP-regulated environment; or laboratory IT and system administration in a