Process Engineer

Job DescriptionResponsibilities: Lead technical/validation/equipment/facility/process improvements projects. Provide technical process support for routine clinical and/or commercial cell therapy manufacturing at the CMO. Support production related investigations, ensuring compliance with internal standards and regulatory requirements. Identify and propose continuous process improvement projects to management. Support process and procedural changes to improve manufacturing performance, robustness, productivity, safety, and efficiency. Perform data analysis and monitoring of manufacturing processes to understand process capability. Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification. Leverage and maintain strong relationships with external partners. Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites. Maintain permanent inspection readiness and actively support regulatory inspections. Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network. Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product. Share operational and process leaning with the rest of the manufacturing network.Requirements: B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline. Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial). Experience working within Quality Management systems including providing deviation, investigation, and CAPA support. Experience with cellular therapies is strongly preferred. Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting. Familiarity with literature on process development and cell therapy. Excellent communication, writing, organizational, teamwork, and presentation skills Strong interpersonal and leadership skills to work with teams in different functions and organizations.

Created: 2025-10-04