Validation Manager for IT Systems (m/f/x)

Responsibility for consulting the ZEISS segments for the implementation of projects for the validation of IT systems, applications and tools in the context of system implementation or when changing systems, applications or infrastructure Training of internal operational teams to maintain validated/qualified systems in operational operation Development, maintenance and continuous development of the IT Compliance Framework for Validation (Directives, Process and Tooling) Bringing validation requirements into projects and accompanying and monitoring their implementation, ensuring compliance with process specifications and specifying the required validation templates and reports and supporting them in use Improve and implement processes for efficient and GxP-conform design of validation processes Ensuring holistic consideration of legal requirements within the framework of validation projects in coordination with internal experts and stakeholders Support software implementation and qualification of IT infrastructure in validated environments

completed study of computer science, engineering or comparable qualification (multiannual relevant experience in the regulated environment) Experience on the introduction of IT systems in the regulated environment (pharmaceutical industry, medical devices, clinical research) and the maintenance of validation status in the further life cycle very good knowledge of regulatory requirements for computer-assisted systems and corresponding infrastructure (US FDA, 21 CFR Part 11, EU GMP Annex 11, ISO13845, GAMP5) and computer system validation Experience in developing efficient and risk-based validation strategies and their implementation in system implementations and changes Experience with processes and technologies in data and document management safe occurrence in dealing with internal and external contact persons very good English knowledge of word and writing readiness to travel JOBV1_EN