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

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To set the pace with our innovations and make it great. Because there are a lot of fascinating people behind every successful company.

ZEISS employees work in an open and modern environment with numerous development and further training opportunities. Our culture is characterized by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together.

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Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity.

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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

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