• Associate Process Engineer

    Amneal Pharmaceuticals (Piscataway, NJ)


    Description:

    The Associate Process Engineer reports to the Technical Lead or head of Technical Services. Executes Process/Cleaning Validation/Study assignments as per directives. Creates protocols, data collection and analysis and prepare reports under supervision.

    Essential Functions:

    + Prepare validation protocols & reports for manufacturing process and cleaning process qualification; data analysis and prepare reports; execute manufacturing process and cleaning process qualification/validation/study

    + Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements

    + Prepare and review manufacturing batch record and other engineering qualification documents as required

    + Coordinate/oversee the development of new processes or troubleshoot existing ones

    + Review Annual Product Review reports and plot trend analysis & APR reports

    + Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA)

    + Assist in various audits

    Additional Responsibilities:

    + Performs other functions as required or assigned.

    + Complies with all company policies and standards.

    + Initiation of Change Controls and Planned Deviations when required

    + Reviews manufacturing/ Packaging batch records and Engineering qualification documents

    + Performs other functions as required or assigned.

    + Complies with all company policies and standards.