Engineering - Process Engineer - Advent Global Solutions
Seattle, WA 98109
About the Job
Job Description: 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.
Additional Job Requirements:
None
" 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.
Additional Job Requirements:
None
Source : Advent Global Solutions
