Primary responsibilities would include, but are not limited to:
• 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 Client 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.
Desired Background and 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.
Process Engineer • Seattle, WA, United States
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