The Senior CSV Validation Engineer is responsible for planning, executing, and maintaining risk-based validation activities for complex technology platforms in regulated manufacturing environments. This role involves translating regulatory requirements into practical validation deliverables and ensuring systems remain in a validated state through rigorous documentation and testing.
The CSV Quality Engineer Lead will establish and maintain the company's quality management system while providing independent oversight of computerized system validation activities. This role involves developing quality policies, managing compliance processes like CAPA and change control, and preparing the organization for customer audits.