Beschreibung
Computer System Validation Engineer (CSV)
Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.
One of our clients, a leading Medical Device company in Switzerland, is looking for a CSV Engineer. This is a challenging 9-month contract located in Basel, Switzerland.
Your tasks & responsibilities
- Computer Systems validation activities
- Plan and implement qualification/validation activities and projects of new and existing computer systems according to client's internal and external requirements for all departments within client's EMEA
- Plan and implement qualification/validation activities and projects of existing computer systems according to client's Software Development Lifecycle
- 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
- Perform CSV trainings
- Extended Duties include Planning, coordination and execution of activities in cross-plant projects (eg qualification of IT systems and infrastructure needs, validation of software, etc.).
What you must have
- German Fluent
- English Fluent
- Higher education (Engineer or similar)
- Background in IT, at least 3 years work experience
- Responsibility in similar 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
- Experience in CSV system development life cycle
- 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.
What is nice to have
- Validation experience with ERP, MES, LIMS, and Quality Systems
Overview
- Start date: 01.03.2019
- End date: 20.12.2019
- Work location: Basel
- Workload: 100%
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Alexander Russell.