Immunomedics, Inc.

  • Process Engineer, Utilities/Facilities

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(10/16/2018 12:17 PM)
    Job ID
    2018-1351
    # of Openings
    2
    Category
    Facilities
  • Overview

    The Process Engineer, Utilities/Facilities will be the technical resource providing support to portions of the manufacturing process with the goal of ensuring reliable performance and identifying opportunities for continuous improvement. 

    Responsibilities

    Develops a fundamental understanding of the process and equipment. Utilizes technical and engineering tools to troubleshoot and understand the process.
    • Utilizes reports/ data (e.g. UNICORN) to analyze and troubleshoot process issues. Trouble shoots and resolves equipment issues.
    • Serves as a technical resource for the process and equipment and SME for change requests, deviations, and periodic quality reviews to ensure equipment remains in a validated/ qualified state.
    • Investigates deviations and applies root cause analysis tools to determine root cause(s)and establishes resolution/ implementation of CAPA’s to minimize repetitive deviations.
    • Improves process throughput. Utilizes modeling tools to identify bottlenecks and proposes operational or equipment modifications to improve throughput.
    • Routinely assesses process using measurements and data interpretation. Utilizes statistical tools to analyze process data to ensure process is in control and capable.
    • Provides process documentation and operating instructions. Assists with SOP’s and batch record improvements; composes and obtains approval for new equipment SOP’s.
    • Performs risk assessments/ recommendations. Assists with equipment failure risk mitigation, FMEA analysis, process safety assessments, and critical spare part assessments.
    • Implements process improvements. Specifies and purchases new equipment for process improvements. Utilizes quality systems (User requirements, IQ/OQ, functional testing, etc.) for validation of new equipment.

     

    Qualifications

    • Bachelor of Science in appropriate engineering discipline (chemical, mechanical) with at least 5 years’ experience working in a process engineering role preferably in a GMP environment.
    • Experience working in small teams.
    •  Experience in process simulations.
    • Proven work experience in process engineering.
    • Excellent technical skills.
    • Working knowledge of process utilities/facilities cGMP processes and engineering software packages
    • Must possess excellent communication (oral and written), organizational, and interpersonal process related standards.
    • Working knowledge of process engineering software packages
    • Must possess excellent communication (oral and written)

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