Process Engineer

4 days ago


Seattle, Washington, United States Omni Inclusive Full time
Job Summary

We are seeking a highly skilled Process Engineer to join our team at Omni Inclusive. As a key member of our operations team, you will be responsible for ensuring the smooth execution of our manufacturing processes.

Key Responsibilities
  • Develop and implement process protocols and technical reports to support technology transfer and process changes.
  • Monitor and analyze data to understand process capability and identify areas for improvement.
  • Support investigations and ensure compliance with internal standards and regulatory requirements.
  • Review batch records to ensure process control and validated state.
  • Manage tools and templates to quantify impact and criticality for parameters and attributes.
  • Ensure manufacturing processes are in a state of control and harmonized across the cell therapy network.
  • Support continuous improvement for technical and business processes.
  • Leverage professional relationships with external partners.
Requirements
  • B.S. or M.S. in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline with 4-7 years of relevant experience.
  • Experience with cellular therapies is highly preferred.
  • Proficiency in MS Office and experience with JMP is preferred.
  • 4+ years of 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.

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