CSV Validation Engineer

On behalf of one major client in the Pharma industry, Harvey Nash is currently looking for CSV Validation Engineers (support) for Projects in different Swiss locations

Project scope
- Working in an remediation project as CSV Validation Engineer.
- Support for the creation of the new Procedure for CSV Equipment Validation.

Project tasks
- Support Creation Work Frame for CSV Equipment
- Support and consulting during projects handling GxP critical computer systems
- Creation of the Validation documentation for GxP relevant systems.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations.
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
- Threshold tracking from migrations to virtualized environment ie Vblock.
- Forecasting, benefit & charging tracking for the Vblock migrations.
- Managing prioritization across divisional demand.
- Redirection and Windows Lifecycle initiative.

Experience

- Higher education (Engineer or similar) and background in IT and at least 5 years work experience
- Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11.
- Language Skills: German & English fluent.

Additional information:

- Start Date: July 2013
- End Date: 31.12.13
- Location: BASEL

Interested? Then please send your complete CV (word documents preferred) or contact me directly.

I am looking forward to receiving your application.