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Process Engineer

3 months ago

Seattle, United States Intellectt Inc Full time

Hello Everyone,

One of my clients is looking Role: Engineering - Process Engineer , if you’re interested or your skills matches, please share with me your updated resume to sushma@intellectt.com


Job Title: Engineering - Process Engineer

Location: Seattle, WA

Duration: 12 Months


NOTE: Strictly Local Candidates


Job description:

Primary responsibilities:

  • Author study protocols and technical reports, and revise process documents as needed to support technology transfer and process changes.
  • Perform and support data monitoring of manufacturing processes to understand process capability.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
  • Review executed batch records to ensure process is operating within the validated state.
  • Understand and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within BMS and/or CMO unit operations.
  • Ensure manufacturing processes are in a state of control, harmonized across the cell therapy network.
  • Support continuous improvement for technical and business processes.
  • Leverage and maintain professional relationships with external partners.


Experience:

  • B.S. or M.S with 4-7 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline. (PhD overqualified)
  • Experience with cellular therapies is highly preferred
  • 4+ years of MS office, experience with JMP is preferred.
  • 4+ years’ experience in a regulated manufacturing environment is highly preferred.
  • 1+ years of experience in technical writing or deviation writing
  • Flexibility to work across East Coast and West Coast time zones.
  • Excellent communication, writing, organizational, teamwork, and presentation skills
  • Exceptional interpersonal skills to work with teams in different functions and organizations.