• Associate Validation Engineer

    Amneal Pharmaceuticals (Branchburg, NJ)


    Description:

    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.