Immunomedics, Inc.

  • Process Engineer ll

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(3 months ago)
    Job ID
    # of Openings
  • Overview

    The Process Engineer 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.


    • 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 throughout.
    • 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.
    • Excellent technical skills.
    • Knowledge of process related standards.
    • Working knowledge of process engineering software packages
    • Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment. 
    • Strong problem-solving skills
    • Self-Starter with the ability to operate with a minimum of direction
    • Solid basic computer skills


    • Bachelor of Science in appropriate engineering discipline (chemical, mechanical) with at least 2 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.


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