About the Role
Job Title: Computer System Validation (CSV) Lead Location: United StatesThis position is open exclusively to people who are eligible to work in USA.Position SummaryWe 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 ResponsibilitiesLead 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, troubleshooting,...
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