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.

1. 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.

1. 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).

1. 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.

Qualifications

• 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).