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 Positive 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

📌 Senior Officer, Water System (plant Engineering) (Gujarat)
🏢 Amneal Pharmaceuticals
📍 Gujarat