Immunomedics, Inc.

  • Process Engineer, Single Use Technology

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(11/11/2019 6:42 PM)
    Job ID
    2019-1569
    # of Openings
    1
    Category
    Engineering
  • Overview

    The Process Engineer, Automation and Single Use Technology will be the technical resource for the Immunomedics Single Use program, providing engineering expertise to equipment and process assessment and optimization, technical document authoring, continuous improvement, equipment and process quality system ownership, and on-the-floor mentorship for all large-scale processing as it pertains to single use technology. 

    Responsibilities

    • Serves as the large-scale single use technology expert, utilizing technical and engineering tools to troubleshoot and/or optimize the process and single use components.
    • Will assist in analyzing data and creating trending grafts and reports. Supports data trending meetings and discussions with cross functional teams. Trouble shoots and resolves equipment, single use, and process issues.
    • Serves as the technical resource and SME for single use technology related projects and activities.
    • Takes ownership of all technical based quality systems, including change controls, deviations, and CAPAs as assigned by management. Work with Manufacturing and QA to properly manage quality system investigation and closure.
    • Authors technical documents, including but not limited to Tech Transfer protocols, DOE protocols, Campaign summary reports, Process data reports, and CMC sections as assigned by management.
    • Utilizes modeling tools to identify bottlenecks and improve throughput.
    • Serves as on-the floor experts for all process runs as directed by management
    • Assists with SOP and MBR improvements.
    • Supports and/or performs risk assessments/recommendations. Assists with equipment failure risk mitigation, FMEA analysis, process safety assessments, and single use component assessments.
    • Specifies and purchases single use components for process improvements. Supports Validation and Manufacturing departments for validation of single use components
    • Navigate/troubleshoot HMI graphics (Wonderware) and PLC software
    • Experience with Unicorn software (Method writing, Strategy development)
    • Designing, implementing, and supporting electrical hardware systems

    Qualifications

    • BS in appropriate engineering discipline with at least 3 years of industry in a Phase 3/Commercial GMP facility. Additional and equal relevant experience in lieu of formal education will be considered.
    • Experience in planning and execution of technical related projects and activities.
    • Strong technical writing experience.
    • Excellent technical and analytical skills.
    • Thorough knowledge of Single Use Technologies is required. Knowledge of automated systems is desired. Knowledge of Upstream and Downstream technologies is preferred
    • Must possess excellent communication (oral and written), organizational, and interpersonal skills.
    • Strong understanding of cross-functional partnerships and decision-making
    • Comfortable with respectfully challenging convention.
    • Ability to influence up, down, and across levels and departments.
    • Must have ability to work in fast paced environment with an in-process infrastructure

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