Validation Engineer I, Engineering

Company:  Amneal Pharmaceuticals
Location: Brookhaven
Closing Date: 02/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description

Job SummaryThe 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 FunctionsAssist 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 supervisorPerforms re-qualification of equipment, facility and utilities as required under supervisionIdentify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solutionDraft Standard Operating Procedure(SOP) for new operational equipmentSupports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical serviceWorks with equipment vendors to collect equipment manual and other required documentsClosely works with the maintenance & facility teams to complete new equipment installation as per project requirement.Additional ResponsibilitiesAssist with engineering projects and performs other duties as assigned.

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