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.