Process Engineer - Cell Therapy & Process Improvement

TechDigital Group; Seattle (WA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

TechDigital Group in Seattle is seeking a Biochemical/Biomedical Engineer to author study protocols, support technology transfer, and monitor manufacturing processes for capability and control.

Ideal candidates have 4–7 years in regulated manufacturing, experience with cellular therapies, and strong writing and communication skills. Willingness to collaborate across East/West Coast time zones is required.

Qualifications

• 4–7 years in Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology
• Experience with cellular therapies preferred
• 4+ years in a regulated manufacturing environment
• 1+ years in technical writing or deviation writing

Responsibilities

• Author study protocols and technical reports; revise process documents for tech transfer and changes
• Monitor manufacturing data to assess process capability
• Support production investigations; ensure compliance with internal standards and regulatory requirements
• Review batch records to ensure operation within validated state
• Understand and manage tools/templates to quantify impact and criticality for parameters and attributes
• Ensure manufacturing processes are in control and harmonized across the network
• Support continuous improvement for technical and business processes
• Maintain relationships with external partners

Skills

Biochemical Eng

Cell Biology

Regulatory Compliance

Data Analysis JMP

Education

Bachelor's or MS in Biochemical/ Chemical/ Biomedical Eng or related

Tools

MS Office

JMP

Job description

TechDigital Group in Seattle is seeking a Biochemical/Biomedical Engineer to author study protocols, support technology transfer, and monitor manufacturing processes for capability and control.

Ideal candidates have 4–7 years in regulated manufacturing, experience with cellular therapies, and strong writing and communication skills. Willingness to collaborate across East/West Coast time zones is required.