Process Engineer

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

Primary Responsibilities

would include, but is not limited to:

• Author study protocols and technical reports, and revise process documents as needed to support technology transfer and process changes.
• Perform and support data monitoring of manufacturing processes to understand process capability.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Review executed batch records to ensure process is operating within the validated state.
• Understand and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within Client and/or CMO unit operations.
• Ensure manufacturing processes are in a state of control, harmonized across the cell therapy network.
• Support continuous improvement for technical and business processes.
• Leverage and maintain professional relationships with external partners.

Desired Background and Experience

• B.S. or M.S with 4-7 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline (PhD overqualified).
• Experience with cellular therapies is highly preferred.
• 4+ years of MS office, experience with JMP is preferred.
• 4+ years' experience in a regulated manufacturing environment is highly preferred.
• 1+ years of experience in technical writing or deviation writing.
• Flexibility to work across East Coast and West Coast time zones.
• Excellent communication, writing, organizational, teamwork, and presentation skills.
• Exceptional interpersonal skills to work with teams in different functions and organizations.