Senior Engineer, Manufacturing Sciences

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

Job Summary: This role offers an exciting opportunity for a skilled engineer to impact the efficiency, quality, and innovation within downstream biologics processing at a KBI Biopharma. As the MS&T Senior Engineer - Downstream, you will be pivotal in supporting cGMP production operations through expertise in process engineering, technology transfer, and validation. Working closely with cross-functional teams and directly engaging with clients, you will lead the implementation of process improvements, troubleshoot technical issues, and ensure that client and regulatory standards are consistently met. This position is ideal for an experienced engineer with a strong background in downstream processes and biologics, who thrives in a collaborative environment and is committed to driving excellence in manufacturing science and technology. The role offers opportunities for professional growth, exposure to cutting-edge technologies, and a dynamic work environment where your contributions will directly influence production success and client satisfaction.

Your Duties and Responsibilities

• Technical Support and Process Ownership: Provide technical expertise for cGMP production runs, ensuring efficient and reliable downstream operations.
• Oversee and support the transfer of processes from development to manufacturing, including critical process descriptions and requirement definitions for site implementation.
• Develop and implement process validation, monitoring strategies, and documentation to ensure ongoing compliance and process stability.
• Client Communication and Requirement Definition: Act as the primary point of contact for clients, managing communication to clearly articulate process requirements, expectations, and modifications.
• Facilitate client alignment on process design, transfer plans, and performance criteria, ensuring all production activities meet defined client standards.
• Cross-Functional Collaboration and Team Leadership: Lead cross-functional teams to coordinate process implementation, validation, and optimization projects.
• Work closely with Manufacturing, Validation, QA, Facilities & Engineering, Supply Chain, IT, Automation, QC, and Process Development teams to ensure compliant, efficient process execution.
• Drive effective collaboration to align on process goals, solve complex challenges, and implement improvements.

Your Qualifications

• Educational Background: Bachelor’s degree in science or engineering with a minimum of 9 years of industry experience,OR Master’s degree with at least 7 years of industry experience,OR PhD with at least 5 years of industry experience.
• Skill and Competencies: Proven expertise in biologics, specifically in upstream or downstream processing, technical transfer, and operational support.
• Strong background in cGMP production operations is essential.
• Demonstrated experience in technical transfer and scale-up processes.
• Familiarity with process validation and GMP compliance requirements is highly preferred.
• Previous experience working in a cGMP manufacturing environment is an advantage.
• Detail-oriented and organized, with a strong commitment to quality and regulatory compliance.
• Team-oriented mindset with experience in leading projects and cross-functional initiatives.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.