• Associate Process Engineer

    Amneal Pharmaceuticals (Piscataway, NJ)


    Description:

    The Associate Process Engineer assists with equipment qualification and related engineering documentation, including preparation of protocols, reports, and statistical data analysis to ensure compliance with quality standards. The role also supports troubleshooting, audits, and investigations by identifying root causes and recommending corrective or preventative actions.

    Essential Functions:

    + Support validation protocols & reports for manufacturing equipment qualification; data analysis and prepare reports;

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

    + Troubleshoot equipment and process issues, collaborating with cross-functional teams to implement effective solutions.

    + Support engineering requirements by procuring new equipment, coordinating installation, and assisting with modifications to existing equipment and processes.

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

    + Provide technical support to R&D and production teams, ensuring equipment and process readiness for routine and new manufacturing needs.

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

    + Assist in preparing and executing validation protocols for both automated and manual processes, ensuring compliance with cGMP and company standards.

    + 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.