Brookhaven, NY, 11719, USA
13 days ago
Validation Engineer I, Engineering
Job Summary The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. Essential Functions + Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor + Performs re-qualification of equipment, facility and utilities as required under supervision + Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution + Draft Standard Operating Procedure(SOP) for new operational equipment + Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service + Works with equipment vendors to collect equipment manual and other required documents + Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement. Additional Responsibilities + Assist with engineering projects and performs other duties as assigned.
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