Senior CSV Engineer (m/w)

AUFGABEN

- CSV Engineer = Computer System Validation
- Planning and implementation of qualification / validation activities and projects of new and existing computer systems according to internal and external requirements for all departments within EMEA
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Approving specific computer system validation documentation and acting as software quality assurance
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Performing CSV trainings
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.)

QUALIFIKATIONEN

- Higher education (Engineer or similar) and background in IT and at least 5 years work experience
- Responsility in similar mangement position or extended experience as executer required
- Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11