Water System Operator

Job Description:

• 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).