System Operation & Monitoring:Operate, monitor, and troubleshoot purified water, water for injection (WFI), and pure steam generation systems, including but not limited to, reverse osmosis (RO) units, deionization (DI) units, multi-effect stills, and clean steam generators.Monitor critical parameters such as temperature, pressure, flow rate, conductivity, TOC (Total Organic Carbon), and pH.Respond immediately to alarms and system deviations, initiating corrective actions as per standard operating procedures (SOPs).Preventive & Corrective Maintenance:Perform routine preventive maintenance (PM) on water and steam systems as per the established schedule. This includes filter changes, membrane cleaning, and calibration of sensors.Perform corrective maintenance to address system failures, leaks, or other issues.Coordinate with the maintenance team and external contractors for complex repairs.Documentation & Compliance:Maintain accurate and detailed logbooks and records of all system operations, maintenance activities, and monitoring data.Ensure all documentation is completed in a timely manner and in compliance with cGMP, internal SOPs, and data integrity principles.Participate in internal and external audits (e.g., FDA, EMA) and provide necessary documentation and explanations.Sanitation & Validation:Execute sanitization procedures for the water distribution loops (e.g., thermal or chemical sanitization) on a scheduled basis.Assist in the validation and revalidation activities of the water and steam systems, including Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
