Assistant, Manufacturing Injectables

B) SAT / IQ / OQ / PQ C) Routine Production D) GMP, EHS & Compliance F) Documentation

• 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.
• 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.
• 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.
• 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.
• 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.

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).