Process Engineer

Cell Therapy Process Development Manufacturing EngineerImmediate need for a talented Cell Therapy Process Development Manufacturing Engineer. This is a 06+months contract opportunity with long-term potential and is located in Los Angeles, CA (Onsite).Key Responsibilities:Design and execute cell therapy process development experiments using automated platforms.Perform hands-on laboratory work in a cell culture environment.Execute aseptic processing activities in an ISO 5 environment.Perform cell culture activities including cell passaging, sampling, fluid handling, media formulation, reagent management, and cryopreservation.Develop, optimize, and characterize processes supporting autologous T-cell therapies.Evaluate new technologies, materials, equipment, and process improvements for implementation into GMP manufacturing.Perform process and equipment analysis and trend performance to identify process improvement opportunities.Support development of manufacturing equipment, including hardware, software, single-use systems, and user requirements.Apply Design of Experiments (DOE) and statistical analysis to process development studies.Use tools such as JMP and/or Minitab to analyze experimental data.Apply bioprocess engineering principles related to bioreactors, scale-up, scale-out, hydrodynamics, mass transfer, and process monitoring.Support technology transfer from process development into clinical and commercial GMP manufacturing.Provide technical training to GMP manufacturing personnel.Support manufacturing operations and troubleshooting activities as needed.Draft and review protocols, SOPs, manufacturing procedures, batch records, technical reports, and summary reports.Prepare presentations and communicate experimental results to cross-functional teams, senior leadership, and external collaborators.Collaborate with teams across research, process development, engineering, quality, and manufacturing.Key Requirements and Technology Experience:MS in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related field with 2+ years of relevant pharmaceutical/biotechnology manufacturing and process development experience; orBS in a related engineering/biotechnology discipline with 4+ years of relevant experienceAS in a related discipline with 5+ years of relevant experience; orHigh School Diploma with 6+ years of relevant pharmaceutical/biotechnology manufacturing and process development experience.Experience in cell therapy process development or closely related bioprocess development.Experience working with automated cell therapy platforms.Hands-on cell culture experience.Experience with aseptic processing in an ISO 5 environment.Practical experience with bioreactors and bioprocess development.Experience with Design of Experiments (DOE) and statistical analysis.Experience using JMP, Minitab, or similar statistical software.Working knowledge of cGMP/GMP manufacturing and pharmaceutical/biotechnology regulatory requirements.Understanding of cell biology, including cell populations, differentiation, phenotype markers, and metabolic pathways.Knowledge of bioprocessing principles, including scale-up/scale-out, hydrodynamics, mass transfer, and bioreactor design/monitoring.Experience with technology transfer and/or GMP manufacturing support.Strong troubleshooting, critical-thinking, and problem-solving skills.Strong technical writing, communication, and presentation skills.Ability to work independently while collaborating effectively in a fast-paced, cross-functional environment.Flow cytometrymRNA handling or mRNA process developmentAutomated or closed cell-processing systemsSingle-use bioprocessing technologiesCell therapy manufacturingProcess characterizationRegulatory documentation and technical reports