Ensure all automation systems remain in a validated state in compliance with GMP, GAMP 5, 21 CFR Parts 210, 211, and Part 11 requirements, including authoring, reviewing, and approving system lifecycle documentation (URS, FRS, DDS, risk assessments, commissioning and qualification protocols, reports). The Senior Automation Engineer will lead automation strategy, support deviation investigations and CAPAs, enable process improvements, support technology transfer activities, and serve as the primary subject matter expert (SME) during internal and external regulatory inspections.