Assistant, Manufacturing Injectables

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).