Author, review, execute, and maintain validation lifecycle deliverables, including validation plans, requirements, risk assessments, configuration or design specifications, test protocols and scripts, traceability matrices, and validation summary reports. Strong knowledge of GxP requirements, GAMP 5 and risk-based CSV/CSA principles, 21 CFR Part 11 and EU Annex 11 as applicable, ALCOA+ data integrity principles, and quality processes including change control, deviations, CAPA, and document control.