Senior Downstream MS&T Engineer: Transfer & Validation

KBI Biopharma, Inc.; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks an MS&T Senior Engineer – Downstream to drive process improvements, support cGMP operations, and lead technology transfer initiatives across biologics downstream processing.

You will troubleshoot complex issues, validate processes, and ensure alignment with client and regulatory standards. This role requires a strong background in downstream biologics, cross-functional leadership, and hands-on experience with transfer, scale-up, and validation activities,

Qualifications

• Bachelor’s degree in science or engineering with extensive industry experience.
• Proven expertise in biologics downstream processing and technical transfer.
• Strong background in cGMP production operations and GMP compliance.
• Experience with technical transfer, scale-up, and process validation.
• Prior cGMP manufacturing experience is advantageous.
• Detail-oriented, organized, and able to lead cross-functional projects.

Responsibilities

• Provide technical expertise for cGMP production runs and downstream operations.
• Oversee transfer of processes from development to manufacturing with site implementation.
• Develop and implement process validation, monitoring, and documentation.
• Serve as primary client contact to define process requirements and changes.
• Lead cross-functional teams to coordinate implementation, validation, and optimization.
• Collaborate with Manufacturing, QA, Validation, Facilities, IT, and Process Development.

Skills

Biologics downstream

Technical transfer

Process validation

cGMP operations

Cross-functional leadership

Project management

Education

Bachelor’s degree in science or engineering

Master’s degree (preferred)

PhD (preferred)

Job description

KBI Biopharma, Inc. in Durham, NC seeks an MS&T Senior Engineer – Downstream to drive process improvements, support cGMP operations, and lead technology transfer initiatives across biologics downstream processing.

You will troubleshoot complex issues, validate processes, and ensure alignment with client and regulatory standards. This role requires a strong background in downstream biologics, cross-functional leadership, and hands-on experience with transfer, scale-up, and validation activities,