Senior CSV Validation Engineer

For a project in South West Switzerland, we are looking for a SENIOR CSV Validation Engineer

Overall Responsiblities

- Project Quality Support in the CSV Equipment Legacy Review.
- Project Quality Support in CSV Equipment Remediation Projects..
- Team Lead of Site CSV Equipment Team

Tasks

- Cover the part of the GxP-Compliance in the project.
- Creation of the Validation documentation for GxP relevant system elements
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations

Extended Duties

- Planning, coordination, execution and reporting of activities related to the project Requirements
- Higher education (Engineer or similar) and background in IT
- Experience in similar position or extended experience as executer required.
- Knowledge of national and international regulations and standards
- GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11
- CSV Experience in the area of Medical Devices Manufacturing
- Excellent Communication skills
- Fluent in English and German - oral and written- both are essential

Are you interested in this position? We are looking forward to receive your application