Manufacturing Engineer II
Dawar Consulting•Santa Monica, CA
•Onsite
About The Position
Our client, a world leader in biotechnology and life sciences, is looking for a “Manufacturing Engineer II”. This role will focus on hands-on process development, process characterization, technology transfer, and implementation of new technologies for clinical and commercial manufacturing. The successful candidate will work cross-functionally with Research, Development, Manufacturing, Quality, and Engineering teams to develop robust, scalable, and GMP-compliant cell therapy processes.
Requirements
- MS with 2+ years, BS with 4+ years, AS with 5+ years, or equivalent experience in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline.
- Experience in pharmaceutical/biotechnology manufacturing and process development.
- Hands-on experience with automated cell therapy platforms.
- Strong cell culture and aseptic processing experience in an ISO 5 environment.
- Practical knowledge of cGMP manufacturing and pharmaceutical/medical-device regulatory requirements.
- Hands-on process development experience with bioreactors, process monitoring, and DOE/statistical analysis.
- Understanding of bioprocess engineering principles including scale-up/scale-out, hydrodynamics, mass transfer, and bioreactor design.
Nice To Haves
- Flow cytometry experience.
- mRNA handling and process development experience.
- Experience with automated cell therapy manufacturing platforms.
- Experience supporting technology transfer into GMP manufacturing.
- Experience with JMP, Minitab, or other statistical/process modeling tools.
Responsibilities
- Design and execute hands-on laboratory experiments for cell therapy process development, characterization, and optimization using automated platforms.
- Develop and evaluate cell culture processes, materials, technologies, and equipment for introduction into GMP manufacturing.
- Perform cell culture and aseptic processing activities in an ISO 5 environment, including cell passaging, sampling, fluid handling, media preparation, reagent management, and cryopreservation.
- Analyze and trend process and equipment performance; identify opportunities for process improvements and troubleshoot technical issues.
- Support development and implementation of cell therapy manufacturing equipment, including hardware, software, single-use systems, and user requirements.
- Support technology transfer, scale-up/scale-out, process implementation, and GMP manufacturing operations.
- Apply Design of Experiments (DOE) and statistical analysis using JMP, Minitab, or similar tools.
- Prepare and review protocols, SOPs, manufacturing batch records, technical reports, and regulatory-supporting documentation.
Benefits
- Medical
- Paid Sick Leave
- 401 (k)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
