MSAT Process Engineer, Cell Therapy Manufacturing

Orca-Bio; Princeton (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

Orca Bio is establishing East Coast manufacturing operations to deliver high-precision cell therapy products. The MSAT Process Engineer will improve efficiency and safety of the drug product manufacturing process, manage lifecycle of clinical and commercial products, and support investigations and change controls.

You will monitor processes, generate metrics, implement process improvements, perform root cause analysis, and prepare validation protocols.

Qualifications

• B.S. in Engineering or similar field.
• 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries.
• Prior experience in regulated, GMP manufacturing operations

Responsibilities

• Monitors existing products and processes on an ongoing basis.
• Generates metrics and reports for process monitoring and continuous process verification.
• Supports process improvements and changes including electronic batch record creation and modifications.
• Investigates process events and implements corrective and preventive actions.
• Provides troubleshooting support for manufacturing events, equipment performance and material issues.
• Performs root cause analysis to identify causes and determine corrective actions.
• Authors, executes and owns change controls, technical protocols, reports and activities to support improvements.
• Writes and ensures execution of validation protocols and testing in line with required life cycle management activities.

Skills

Process engineering

GMP manufacturing

Problem solving

Communication

Education

B.S. in Engineering

Tools

Electronic batch records (EBR)

Validation protocols

Job description

Orca Bio is establishing East Coast manufacturing operations to deliver high-precision cell therapy products. The MSAT Process Engineer will improve efficiency and safety of the drug product manufacturing process, manage lifecycle of clinical and commercial products, and support investigations and change controls.

You will monitor processes, generate metrics, implement process improvements, perform root cause analysis, and prepare validation protocols.