Description
We are now recruiting for an experienced Computer System Validation Engineer.Tasks:
Planning and implementation of qualification / validation activities and projects of new and existing
computer systems according to internal and external requirements for all departments
Advisory and support of application owners to build and maintain GMP conform systems
Support and consulting during projects handling GxP critical computer systems
Creating specific computer system validation documentation
Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
Planning and implementation of qualification / validation activities and projects of existing computer systems according to Software Development Lifecycle
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.).
Requirements:
Higher education (Engineer or similar) and background in IT and at least 3 years work experience
Prior experience in a similar position
Knowledge of regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
Experience in CSV system development life cycle is required.
Background in Quality Systems is required, as the procedures to revise are related directly to the quality of the product or the quality system of the manufacturing.
Minimal language skills: English & German fluent
Please contact Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.