KBI: US - Senior Engineer, Manufacturing Sciences

KBI Biopharma • Durham, NC

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About The Position

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.

Requirements

• 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.
• 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.
• 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.

Nice To Haves

• Familiarity with process validation and GMP compliance requirements is highly preferred.
• Previous experience working in a cGMP manufacturing environment is an advantage.

Responsibilities

• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior