Specialist - Data Integrity / CSV

pAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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. /p pAs 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. /p h3Job Function: /h3 pQuality /p h3Job Sub Function: /h3 pQuality Control /p h3Job Category: /h3 pProfessional /p h3All Job Posting Locations: /h3 pSchaffhausen, Switzerland /p h3Job Description: /h3 h3About Innovative Medicine /h3 pOur 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. /p pJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. /p pLearn more at /p pWe are searching for a passionate individual to join our Quality Control team us as a bSpecialist - Data Integrity / CSV /b (80-100%) in bSchaffhausen /b, Switzerland. /p h3Purpose: /h3 pYou 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. /p h3You will be responsible for: /h3 h3Laboratory Computerized Systems Lifecycle: /h3 ul liEnsure timely and cost-effective execution of software qualification, validation, and lifecycle activities for GMP-relevant laboratory computerized systems. /li liCoordinate 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. /li liCreate, maintain, and update SOPs and work instructions within the assigned area of responsibility. /li /ul h3Projects, Infrastructure Technical Support: /h3 ul liSupport and execute cross-functional projects related to laboratory equipment qualification, analytical software implementation, Windows lifecycle activities, system upgrades, and infrastructure changes. /li liProvide 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. /li /ul h3Compliance, Controls Non-Conformances: /h3 ul liEnsure compliance with applicable GMP, EHS, SOX, and internal procedural requirements associated with the role. /li liSupport and manage non-conformances, including technical assessment, documentation, impact or risk evaluation, and implementation of preventive and corrective actions (CAPAs). /li /ul h3Qualifications / Requirements: /h3 ul liPh.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. /li li 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 quality-controlled laboratory setting. /li liAdditional IT experience, such as Windows administration, analytical software administration, user access management, application troubleshooting, or collaboration with IT support organizations or external vendors, is considered an advantage. /li liExperience with Quality Risk Management in accordance with ICH Q9, including data and process mapping. /li liStrong understanding of data integrity and data governance principles, with the ability to apply them in GMP-relevant laboratory processes and computerized systems. /li liExperience contributing to or coordinating cross-functional projects, ideally involving laboratory systems, software implementation, infrastructure changes, or compliance-related improvements. /li liExperience in managing non-conformances, preparing impact assessments, and implementing CAPA actions. /li liProficient use of Microsoft Office applications and standard business productivity tools. /li liExcellent organizational and communication skills, a goal-oriented working style, and a strong can-do mindset. /li liGood command of English, including the ability to read, write, and review technical and GMP-relevant documentation; good command of German will be an added advantage. /li /ul h3What We Offer /h3 ul liOpportunities to shape laboratory innovation in a global company at the forefront of healthcare /li liAccessible location in beautiful Schaffhausen /li liCollaborative, inclusive work environment that values work-life balance, cross-functional teamwork, and continuous improvement /li /ul pAt Johnson Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. /p p#RPOEMEA /p p#LI_Onsite /p pAnalytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy /p #J-18808-Ljbffr