(Senior) Consultant Computer System Validation
vor 3 Wochen
Job OverviewAs a (Senior) Consultant - Computer System Validation (CSV), you will lead validation initiatives to keep GxP systems compliant and audit-ready (e.g., 21 CFR Part 11/820, EudraLex, GAMP 5). You will define lifecycle strategies, author/execute tests, and steer automation across cloud and enterprise platforms (e.g., SAP, Veeva, CTMS, MES, LIMS), partnering with IT, Quality, and Regulatory in Agile/DevOps settings. You will also advise on GxP AI validation and strengthen documentation and quality processes (change, deviations, CAPA) while managing multiple projects.Important Note: This is a pipeline posting to build our freelancer pool. There is no active project for this role today. We will review profiles on a rolling basis and contact you when a matching project starts.Key ResponsibilitiesLead and oversee computer system validation (CSV) efforts for life sciences clients, ensuring adherence to regulatory requirements such as 21 CFR Part 11 and 21 CFR Part 820, but not limitedDevelop and implement comprehensive lifecycle documentation for GxP relevant computer systems, including the creation and execution of test protocolsReview technical documentation and support IT compliance strategies to maintain the security, reliability, and regulatory compliance of computer systemsCollaborate with cross-functional teams, including IT, Quality, and Regulatory, to design and execute validation plans for both new and existing computer systems and digital initiativesProvide expert guidance and support on CSV and automation testing, ensuring best practices and regulatory complianceExperienced in DevOps, Agile, Scrum, Waterfall, and ITIL methodologies, with a strong understanding of industry best practicesExperience on validation of GxP AI SolutionsQualifications, Skills and ExperienceBachelor’s or Master’s degree in Computer Science, Engineering, Pharmaceuticals, or a related fieldMinimum of 5 to 13 years of experience in computer system validation (CSV), Infrastructure qualification, IT compliance, testing automation, or related disciplinesIn-depth knowledge of relevant regulations and industry best practices, including FDA regulations, EudraLex and GAMP5Proven ability to lead and manage multiple CSV projects and digital initiatives, including documentation development, testing efforts, and compliance assuranceExperience with testing automation tools, process-controlled systems, application lifecycle management tools and paper-based testingStrong communication skills with the ability to work effectively with cross-functional teamsExpertise in cloud-based solutions, and on different critical systems like SAP, Clinical Trial Management Systems (CTMS), Veeva Vault, Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), electronic Lab Notebooks (eLN), change management, deviation and CAPA processes, as well as experience with AI/ML, automation, and Robotic Process Automation (RPA) is a plusStrong facilitation skills with excellent organizational and interpersonal abilitiesWillingness to travel to customer site as requiredExcellent command of German, spoken and written
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