Team Member Engineering (Water System)

To operate, monitor, maintain, and document the performance of Purified Water (PW), Water for Injection (WFI), Pure Steam, and associated utility systems in compliance with GMP, data integrity, safety, and regulatory requirements.

Key Responsibilities 1.

System Operation & Monitoring Operate and monitor PW, WFI, Pure Steam Generator (PSG), and water distribution systems.

Perform routine checks of critical parameters such as conductivity, TOC, temperature, pressure, flow, and tank levels.

Monitor SCADA/BMS/HMI systems and respond to alarms promptly.

Ensure continuous supply of PW, WFI, and Pure Steam to production areas. 2.

Documentation & Compliance Maintain logbooks, checklists, and records accurately as per GDP requirements.

Record operational data at scheduled intervals.

Ensure compliance with SOPs, GMP, EHS, and Data Integrity requirements.

Support audit preparation and provide records during internal and external audits. 3.

Sampling & Testing Perform routine PW, WFI, and Pure Steam sampling as per approved schedules.

Coordinate with QC for analysis and follow up on results.

Support investigation and corrective actions for out-of-specification or adverse trends. 4.

Preventive Maintenance Support Assist engineering personnel during preventive maintenance and calibration activities.

Support replacement of filters, valves, instruments, cartridges, UV lamps, and other equipment.

Verify equipment availability and readiness after maintenance activities. 5.

Cleaning & Sanitization Execute thermal and chemical sanitization activities as per SOPs.

Monitor sanitization parameters and document results.

Ensure cleanliness and housekeeping of water system areas. 6.

Deviation, Incident & CAPA Support Report abnormalities, breakdowns, leaks, alarms, and quality concerns immediately.

Participate in deviation investigations and root cause analysis.

Implement assigned CAPA actions within timelines. 7.

Safety Responsibilities Follow all plant safety procedures and permit-to-work requirements.

Use appropriate PPE during operations and maintenance activities.

Educational Qualification Diploma/Graduation in Mechanical, Electrical, Instrumentation Engineering or related field is mandatory.

Minimum Work Experience 2-5 years of experience in pharmaceutical utility operations preferred.

Knowledge of PW, WFI, Pure Steam, RO, EDI, UF, and distribution systems.

Skills & Attributes Functional Skills Calibration Computer System Validation Instrumentation Preventive Maintenance Programmable Logic Controllers Works effectively with cross-functional teams to troubleshoot issues, implement solutions, and drive continuous improvement.

Critical Exposures Experience in performing calibration of laboratory instruments, manufacturing equipment, and utilities in compliance with cGMP and regulatory standards is desired.

Experience in Pharmaceutical, Biotechnology, Medical Devices, Life Sciences industry is desired.

Exposure to developing and managing calibration schedules to ensure timely and compliant calibration of critical equipment is preferred.

Experience in documenting calibration activities, including calibration certificates, deviation handling, and audit readiness, is desired.

Experience in using Computerized Calibration Management Systems (CCMS) and digital calibration tools is desired. "