Manufacturing Engineer II

Dawar Consulting; Santa Monica (CA); Vor Ort; USD 69.000 - 74.000; Vollzeit

Benefits dieser Stelle

Medical

Paid Sick Leave

401(k)

Zusammenfassung

Our client in Santa Monica, CA seeks a Manufacturing Engineer II to lead hands-on cell therapy process development and transfer to GMP manufacturing. You will work cross-functionally with R&D, Manufacturing, Quality, and Engineering to develop scalable, GMP‑compliant cell therapy processes.

The role focuses on process development, technology transfer, and implementation of new technologies for clinical and commercial manufacturing, with ISO 5 environment experience required.

Qualifikationen

• MS with 2+ years, BS with 4+ years, AS with 5+ years, or equivalent in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or 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.

Aufgaben

• 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 DOE and statistical analysis using JMP, Minitab, or similar tools.
• Prepare and review protocols, SOPs, manufacturing batch records, technical reports, and regulatory-supporting documentation.

Kenntnisse

Cell culture

Aseptic processing

DOE & statistics

Scale-up/scale-out

Process development

Bioreactors

Ausbildung

MS in Biochemical/ Chemical/ Biomedical Eng

BS in Biochemical/ Chemical/ Biomedical Eng

AS in related engineering field

Tools

JMP

Minitab

Jobbeschreibung

Manufacturing Engineer II

Santa Monica, United States | Posted on 09/11/2026

Our client, a world leader in biotechnology and life sciences, is looking for a “Manufacturing Engineer II”.

Location: Santa Monica, CA

Job Duration:12 Months - Contract To Hire

Rate: $50-$54.50/hr on W2

Company Benefits: Medical, Paid Sick Leave, 401 (k)

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.

Key Responsibilities

• Design and execute hands‑on laboratory experiments forcell therapy process development, characterization, and optimizationusing 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 anISO 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 ofcell therapy manufacturing equipment, including hardware, software, single‑use systems, and user requirements.
  
• Supporttechnology transfer, scale‑up/scale‑out, process implementation, and GMP manufacturing operations.
  
• ApplyDesign 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.
  

Required Qualifications & Experience

• MS with 2+ years, BS with 4+ years, AS with 5+ years, or equivalent experience inBiochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline.
  
• Experience inpharmaceutical/biotechnology manufacturing and process development.
  
• Hands‑on experience withautomated cell therapy platforms.
  
• Strong cell culture and aseptic processing experience in anISO 5 environment.
  
• Practical knowledge ofcGMP manufacturing and pharmaceutical/medical-device regulatory requirements.
  
• Hands‑on process development experience withbioreactors, process monitoring, and DOE/statistical analysis.
  
• Understanding of bioprocess engineering principles includingscale‑up/scale‑out, hydrodynamics, mass transfer, and bioreactor design
  

Preferred Qualifications

• 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.