Description
Krystal Biotech is seeking a Computer System Validation (CSV) Associate to support the implementation, qualification, maintenance, and lifecycle management of GxP computerized systems across manufacturing, quality control, and other regulated business areas. The role involves developing and maintaining validation documentation, supporting system changes and audits, collaborating with cross-functional teams, and ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements. A bachelor’s degree and at least two years of experience in computer system validation, quality systems, or IT compliance in a regulated environment are required.
