Job Description
Job Description
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
Qualifications
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.
