• Manager, Process Engineering

    Amneal Pharmaceuticals (Brookhaven, NY)


    Description:

    In this role, the Associate Manager will lead and support the installation and integration of Blow-Fill-Seal (BFS) systems, HVAC units, sterilizers, and other essential utilities, ensuring compliance with design specifications and operational standards. The Associate Manager will oversee technology transfer for the BFS platform to facilitate seamless adoption and manage validation processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

    Schedule:

    1st Shift 8am-4:30pm Monday to Friday

    Essential Functions:

    + Lead the design, development, implementation, optimization of the machinery, equipment, and utilities required for sterile BFS operations. Lead project management efforts for new equipment installation, facility upgrades, and process improvements, cost reduction, improved efficiencies, and enhancement of overall operational regulations.

    + Lead the qualification and validation of sterile processes, ensuring compliance with FDA, ISO, and other regulatory standards. Prepare, review, and execute process validation protocols, reports, and SOPs.

    + Monitor and document process performance and ensure compliance with internal and external regulations.

    + Manage, guide, and mentor engineers and technicians, providing technical support and expertise in sterile process engineering. Foster a collaborative and efficient team environment, encouraging continuous learning and professional development.

    + Identify and resolve process-related issues, providing technical support for production teams. Utilize data analysis tools to monitor process performance and recommend improvements. Conduct root cause analysis of deviations and implement corrective actions as needed.

    + Collaborate with cross-functional teams to ensure successful process development and transfer to production. Provide technical expertise and guidance to other engineers, operators, and technicians. Develop and conduct training for production personnel on sterile process procedures and best practices.