Immunomedics, Inc.

Senior Process/Automation Engineer

Job Locations US-NJ-Morris Plains
Posted Date 1 month ago(5/5/2020 3:52 PM)
Job ID
# of Openings


The Senior Process/Automation Engineer, Manufacturing 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 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.


  • 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 monoclonal antibody processes, equipment, automation and engineering software packages
  • Must possess excellent communication (oral and written), organizational, and interpersonal process related standards.
  • Working knowledge of process engineering software packages


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