Ihre 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.)

Ihre 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