CSV Validation Engineer

For our Medical Device company based in Solothurn we are looking for

CSV VALIDATION ENGINEER

Overall Responsibilities:
*Project Quality Support in the CSV Equipment Legacy Review
*Project Quality Support in CSV Equipment Remediation Projects

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
*Team Player
*Excellent Communication skills

Language Skills:
*English fluent, German FluentMichael Bailey International is acting as an Employment Business in relation to this vacancy.