Assistant, Manufacturing Injectables
Amneal Pharmaceuticals
- 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.
- 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).