Manufacturing Engineer II

dawarconsulting; Santa Monica (CA); On-site; USD 69,000 - 75,000; Full time

Benefits offered by this job

Medical

Paid Sick Leave

401 (k)

Job summary

Our client in Santa Monica, CA seeks a Manufacturing Engineer II for hands-on process development in cell therapy manufacturing. The role focuses on development, characterization, tech transfer, and implementation of new GMP processes for clinical and commercial use.

You will work with Research, Development, Manufacturing, Quality, and Engineering teams to build robust, scalable processes and ensure GMP compliance. Prior experience with automated platforms and bioreactors is essential.

Qualifications

• MS with 2+ years, BS with 4+ years, AS with 5+ years, or equivalent.
• 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.

Responsibilities

• Design and execute lab experiments for cell therapy process development and optimization.
• Develop and evaluate cell culture processes, materials, technologies, and equipment for GMP manufacturing.
• Perform cell culture and aseptic processing activities in an ISO 5 environment.
• Analyze and trend process and equipment performance; identify opportunities for improvements.
• 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.

Skills

Cell culture

Aseptic processing

Process development

DOE / statistics

GMP compliance

Automation platforms

Education

MS in Biochemical / Biomedical Engineering

BS in Biochemical / Chemical Engineering

AS in related discipline

Tools

JMP

Minitab

Single-use systems

Job description

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

Position Details

• 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)

Job Description

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 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.

Required Qualifications & Experience

• 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

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.