Senior Officer, Water System (Plant Engineering)

The Officer – Water System is responsible for the operation, monitoring, and maintenance of SRO/DRO water for injection (WFI), and clean steam systems used in the injectable manufacturing unit of a pharmaceutical plant. This role ensures that water systems operate efficiently, comply with regulatory standards (e.g., cGMP, WHO, USFDA, EU-GMP), and support aseptic manufacturing processes.

Key Responsibilities:

Operation & Monitoring

Operate and monitor water system utilities including Raw Water Treatment, Softener, RO Plant, Purified Water Generation, WFI Generation (Multi-effect Distillation), Storage & Distribution, and Clean Steam Generators.

• Record critical parameters (e.g., temperature, conductivity, TOC, pressure) as per SOPs and BMRs.
• Ensure continuous availability of water systems for injectable operations.
• Preventive & Breakdown Maintenance
• Carry out routine preventive maintenance as per the schedule.
• Assist in troubleshooting and resolving breakdowns to minimize downtime.
• Coordinate with maintenance teams or OEM vendors for major repairs.

Compliance & Documentation

• Maintain logbooks, equipment qualification records, and calibration records.
• Ensure adherence to cGMP, GEP (Good Engineering Practices), and safety protocols.
• Participate in regulatory audits and inspections (e.g., USFDA, MHRA, WHO).
• Support in execution and review of validation protocols (IQ/OQ/PQ) of water systems.
• Sampling & Testing Support
• Coordinate with QA/QC for routine sampling and microbiological/chemical analysis of water.
• Ensure corrective actions in case of out-of-specification results or deviations.

Continuous Improvement

Suggest improvements in system efficiency, automation, and compliance.

Participate in root cause analysis (RCA) and CAPA implementation.

Skills:

Technical Skills:

Sound knowledge of water system equipment (RO, MGF, MEE, WFI, Clean Steam). - Proficient

Understanding of GMP guidelines related to injectable water systems. - Proficient

Familiarity with SCADA, PLC systems is a plus - Proficient

Soft Skills:

Attention to detail, documentation accuracy. - Proficient

Good communication and teamwork skills. - Proficient

Proactive and safety-conscious mindset. - Beginner

 Diploma/ Bsc. in any Engineering Field, 

Total Experience 5-8 Years in operation of water system for sterile manufacturing plant, Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.