Process Engineer

Primary Responsibilities would include, but is 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. #J-18808-Ljbffr TechDigital Group