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.
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.
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.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
