Key Roles & Responsibilities

Water System Operations

- Operate and monitor Raw Water, Soft Water, DM Water, RO, EDI, PW, WFI, and Pure Steam generation systems.
- Ensure continuous availability of pharmaceutical-grade water as per production requirements.
- Monitor system parameters such as conductivity, TOC, temperature, pressure, flow rate, and microbial trends.
- Ensure water generation, storage, and distribution systems operate within validated limits.
- Perform routine inspections and operational checks of utility equipment.

Preventive & Breakdown Maintenance

- Execute preventive maintenance activities as per approved schedules.
- Attend breakdowns and ensure timely restoration of water systems.
- Coordinate replacement of pumps, valves, instruments, membranes, filters, and UV systems.
- Perform troubleshooting of RO, EDI, distillation units, heat exchangers, and distribution loops.
- Ensure equipment reliability through condition monitoring practices.

Compliance & Documentation

- Maintain logbooks, equipment records, maintenance records, and utility checklists.
- Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
- Prepare and review SOPs related to water system operations and maintenance.
- Support internal audits, customer audits, and regulatory inspections.
- Ensure proper documentation of deviations, incidents, and corrective actions.

Validation & Qualification Support

- Support qualification and validation activities of PW, WFI, and Pure Steam systems.
- Participate in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
- Assist in periodic review and requalification activities.
- Support sampling and monitoring activities for water system validation.

Water Quality Management

- Coordinate routine water sampling activities.
- Monitor chemical, physical, and microbiological quality of water systems.
- Review water trend reports and identify potential risks.




- Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and microbial excursions.
- Implement corrective and preventive actions to maintain system integrity.

Energy & Resource Optimization

- Monitor water consumption and utility efficiency.
- Reduce water losses through conservation initiatives.
- Participate in energy-saving and sustainability projects.
- Support optimization of RO recovery and utility system performance.

Safety, Health & Environment

- Ensure safe handling of chemicals used in water treatment systems.
- Follow site safety procedures, permit-to-work systems, and lockout-tagout practices.
- Participate in safety observations, risk assessments, and incident investigations.
- Maintain compliance with environmental and EHS requirements.

Continuous Improvement

- Participate in Lean, Six Sigma, TPM, and operational excellence initiatives.
- Identify opportunities for improving system reliability and efficiency.
- Drive CAPA implementation for recurring utility issues.
- Support digitalization and automation initiatives related to utility operations.

Cross-Functional Coordination

- Coordinate with Production, QA, QC, Validation, Projects, and Engineering teams.
- Support current equipment installations and utility projects.
- Ensure availability of critical spares and maintenance resources.
- Participate in shift handovers and utility review meetings.

Educational Qualification:

- B.Tech/B.E. in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Instrumentation Engineering, Biotechnology Engineering, or related discipline.
- Diploma in Engineering with relevant pharmaceutical utility experience may also be considered.

Experience

- 6-10 years of experience for Engineer level in pharmaceutical, biotech, vaccine, API, or regulated manufacturing industries.
- Hands-on experience in operation and maintenance of PW, WFI, Pure Steam, RO, EDI, and distribution systems preferred.

Experience: 0.00-0.00 Years

📌 Team Member - Engineering (Water Systems) (India)
🏢 Monster - xshruthix
📍 India