Computer System Validation (Csv) Lead

Job Title: Computer System Validation (CSV) Lead Location: United States This position is open exclusively to people who are eligible to work in USA.Position Summary We are seeking an experienced Computer System Validation (CSV) Lead to support validation activities for a newly constructed Sterile Drug Product Clinical Manufacturing Facility.This role will lead CSV strategy, execution, and compliance activities for GMP computerized systems and automation platforms in a fast-paced project environment.Key Responsibilities Lead CSV strategy and execution for GMP computerized systems and automation platforms.Author and execute CSV lifecycle documents including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.Support commissioning, qualification, and validation activities for manufacturing and automation systems.Collaborate with Automation, Engineering, Quality, Manufacturing, and IT teams.Lead deviation investigations, troubleshooti...