A) Design Review & FAT • Understand basket/loading layouts, spray arm motion, and filter housings. • Observe FAT demos of wash steps, detergents dosing, and HMI sequences. • Review utilities (DI/WFI, compressed air) and basic interlocks. • Verify nozzle layout, pump curves, filtration stages, and utilities. • Review interlocks/alarms; confirm safety and emergency stop logic. • Assess drainage paths and potential dead legs. B) SAT / IQ / OQ / PQ • Support IQ/OQ: execute repeated wash cycles, sampling, and visual checks. • Document cycle parameters and assist in reproducibility verification. • Support PQ by preparing standardized loads and recording results. • Lead OQ: pressure/flow checks, sensor calibration, and cycle tuning. • Troubleshoot blocked nozzles, cavitation, and chemical dosing variability. • Support PQ reproducibility and finalize validated parameters. C) Routine Production • Load parts as per pattern; verify chemical dosing and spray arm rotation. • Operate cycles; monitor pressures/temperatures; handle alarms. • Clean machine surfaces and maintain GDP-compliant records. • Perform PM on pumps, seals, filters; manage spares and change parts. • Trend wash performance; reduce rewash rates and downtime. • Coordinate with QA/Validation for periodic verification. D) GMP, EHS & Compliance • Adhere to cGMP, GDP, and site SOPs; ensure data integrity at all times. • Follow aseptic gowning and cleanroom behaviors for Grade A/B/C as applicable. • Comply with EHS guidelines; report near-misses/unsafe conditions promptly. • Maintain housekeeping (5S) and status labeling of equipment and areas. F) Documentation • Complete BMR/BPR entries, equipment logbooks, cleaning and line clearance records. • Support deviation/CAPA, change control, and risk assessments as applicable. • Maintain qualification/validation records during SAT, IQ, OQ, PQ. • Skills & Competencies • Technical: Understanding of equipment design, utilities, interlocks, and control logic. • Operational: Setup, start-up/shutdown, parameter verification, basic troubleshooting. • Behavioral: Attention to detail, teamwork, communication, ownership mindset. • Education & Experience • ITI/Diploma (Mech/Elect/Instr) / B.sc or B.Tech preferred. • 3 to 7 years of experience in sterile injectable manufacturing with hands-on equipment operation, FAT/SAT participation, troubleshooting, and qualification exposure (IQ/OQ/PQ). • Physical & Environmental Requirements • Ability to work in classified cleanrooms; prolonged standing; occasional lifting up to ~20–25 kg. • Willingness to work in rotational shifts and extended hours during validation. • ITI/Diploma (Mech/Elect/Instr) / B.sc or B.Tech preferred. • 3 to 7 years of experience in sterile injectable manufacturing with hands-on equipment operation, FAT/SAT participation, troubleshooting, and qualification exposure (IQ/OQ/PQ).