Beschreibung
CSV Engineer - Mezzovico - 100%
Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.
For our international client based in Mezzovico, Experis is currently looking for a CSV Engineer for a contracting position of 3 months.
General information:
- Start date: 15.01.2018
- End date: 31.03.2018
- Work location: Mezzovico
Tasks & Responsibilities:
- Computer Systems validation
- Implementation of qualification/validation activities and projects of new and existing computer systems according to the 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
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Computer systems according to the Software Development Lifecycle
- Performing CSV trainings
Extended Duties:
Execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
You bring for this role the following qualifications:
-Higher education (Engineer or similar) and background in IT and at least 5 years work experience
-Responsility in similar management 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 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.
-Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
Language requirements: Italian and English spoken and written
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt.