Description
Senior Computer System Validation (CSV) Specialist with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. Responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. Works closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle.
