Process Engineer II, MSAT

3 days ago

West Norriton, Pennsylvania, United States Resilience Government Services, Inc. Full time
Job Summary:

The Process Engineer will work in the Manufacturing Science and Technology (MSAT) group to provide technical support to CMP Manufacturing operations at the Philadelphia, PA site. The responsibility of this role is to support cell therapy production. This is a site-based role in East Norriton, PA.

Key Responsibilities:
  • Leading the introduction of new manufacturing processes to the facility for clinical and commercial manufacturing of cell therapy products.
  • Performing technology transfer from the development laboratory into all phases of GMP manufacturing.
  • Supporting the design, test, and qualification of MES recipes for electronic batch records.
  • Supporting process investigations, equipment and process troubleshooting.
  • Identifying and driving implementation of improvements to maximize throughput and capacity utilization.
  • Defining relevant operational/technical standards and practices for the site.
  • Providing support and content for regulatory submissions.
  • The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved.
  • Provide technical support to GMP operations in a multi-product facility.
  • Function as a technical resource for the resolution of deviations, investigations, and process issues. Complete technical investigations and provide on the floor technical expertise.
  • Generate technical documents (memos, protocols, reports, plans, etc.,) related to technology transfer, process monitoring, process improvements, etc.
  • Actively participate in client meetings and serve as a technical SME.
  • Complete process monitoring tasks that require a variety of statistical and data analysis methods and techniques (e.g., excel, JMP, etc.).
  • Routinely troubleshoot operational issues for process-related operations.
  • Be a technical resource in the evaluation and implementation of process improvements, policy changes, compliance improvements, and optimization programs.
  • GMP Process Design:
    • Provide technical leadership for execution of engineering runs during technology transfer from development to manufacturing.
    • Monitor, track, evaluate, and report data from unit operations to support project/client communication and deliverables.
    • Perform statistical analysis.
    • Respond to and trouble-shoot process issues related to assigned work and areas of expertise.
    • Assess and select equipment to meet process needs.
    • Perform material assessments as required.
    • Develop scientific and technical understanding of unit operations and production processes.
    • Technology Transfer to GMP Production:
      • Participate in technology transfer activities and provide oversight of GMP runs to support technology transfer to production.
      • Perform key project deliverables for technology transfer activities for new client projects.
      • Define and justify critical and key process parameters.
      • Participate in the development of specifications, standard operating procedures, work instructions, and forms to support implementation of new processes.
      • Collaborate with manufacturing as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support.
      • Perform and/or support risk assessment activities including hazard and operability studies.
      • Train production staff to ensure they can perform duties involving new equipment and new processes.
      • Generate protocols and reports for engineering, and clinical GMP runs.
      • Prepare change controls and perform change control assessments according to internal procedures as required.
      • Comply with safety requirements and work to resolve any environmental, health, and safety issues.
      • Optimize processes to effectively and efficiently produce product that meets clients' quality specifications.

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