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Process Engineer

Company: System One
Location: Warren
Posted on: June 12, 2022

Job Description:

Job DescriptionTitle: Process EngineerLocation: Warren, NJStart date: ASAPResponsibilities:

  • We are looking for a Process Engineer to join the External team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department.
  • The position will be responsible for the routine MSAT support to our ex-US CMO partners. This engineer will have responsibilities like an internal MSAT organization for our cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement.
  • This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support.
  • The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply.
  • The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up work force training.
  • Lead technical/validation/equipment/facility/process improvements projects
  • Provide technical process support for routine clinical and/or commercial cell therapy manufacturing at the CMO.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements
  • Identify and propose continuous process improvement projects to management.
  • Support process and procedural changes to improve manufacturing performance, robustness, productivity, safety, and efficiency.
  • Perform data analysis and monitoring of manufacturing processes to understand process capability
  • Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
  • Leverage and maintain strong relationships with external partners
  • Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
  • Maintain permanent inspection readiness and actively support regulatory inspections
  • Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
  • Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product.
  • Share operational and process leaning with the rest of the manufacturing networkRequirements:
    • B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
    • Experience in internal /external contract manufacturing; GMP clinical / commercial manufacturing; Deviation / CAPA support
    • Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)
    • Experience working within Quality Management systems including providing deviation, investigation, and CAPA support
    • Experience with cellular therapies is strongly preferred
    • Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
    • Familiarity with literature on process development and cell therapy
    • Excellent communication, writing, organizational, teamwork, and presentation skillsStrong interpersonal and leadership skills to work with teams in different functions and organizations
    • Create an environment of teamwork, open communication, and sense of urgency
    • Drive strong collaboration within the group and across functions
    • Build trust and effective relationships with peers and stakeholders
    • Foster a culture focused on science and compliance and strong environmental, health, and safety performance
    • Have a mindset of continuous improvement, problem solving, and prevention

Keywords: System One, Elizabeth , Process Engineer, Engineering , Warren, New Jersey

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