Senior Bioprocess Engineer - Scale-Up & GMP Implementation

KBI Biopharma; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma in North Carolina is seeking a Process Engineer to support cGMP manufacturing. You will join a cross‑functional team to define upstream and downstream equipment needs, qualify systems, and drive scale‑up, tech transfer, and continuous improvements.

The role requires a B.S. in chemical or biochemical engineering, 5+ years in bioprocess development or manufacturing, and strong knowledge of GMP, validation principles, and regulatory expectations.

Qualifications

• Bachelor’s in chemical engineering, Biochemical Engineering, or related field
• 5+ years of experience in bioprocess development or manufacturing within the biotech or biopharma industry
• Expertise in biologics, cell therapy, gene therapy, drug substance production processes
• Strong understanding of cGMP regulations, FDA/EMA guidelines, and validation principles
• Proficiency in process modeling and simulation tools
• Demonstrated leadership in cross-functional teams and project management
• Excellent communication, analytical, and problem-solving skills
• Experience with regulatory submissions (IND, BLA, MAA) is a plus

Responsibilities

• You will support equipment commissioning and qualification activities related to new or modified processes.
• Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems.
• Act as the technical SME for upstream and/or downstream equipment and the site clean utilities ensuring proper installation, qualification, and maintenance of these systems.
• Lead process engineering related projects to improve manufacturing operations or implementation of new processing equipment.
• Lead the development, scale-up, and optimization of upstream (cell culture, fermentation) and/or downstream (purification, filtration) processes for biologics or advanced therapies
• Design and execute experiments to improve process robustness, yield, and product quality
• Collaborate with Engineering, Quality, Regulatory, and Manufacturing teams to ensure seamless tech transfer and GMP compliance
• Author and review process documentation including SOPs, and Engineering Studies protocols
• Serve as a technical lead in cross-functional project teams and represent process engineering in regulatory filings and audits
• Evaluate and implement new technologies (e.g., single-use systems, PAT tools, continuous processing) to enhance scalability and efficiency
• Support capital projects including facility design, equipment selection, and commissioning
• Lead risk assessments, and root cause investigations for process deviations
• Communicate with other KBI sites for problem solving and consistency of processes through the organization.
• Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.
• You will perform facility fit activities for various production scenarios.
• You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines.
• The ability to manage multiple concurrent projects and resources.
• Lead and support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
• Providing technical support for equipment modifications, deviations, change controls, and CAPAs.
• Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation.

Job description

KBI Biopharma in North Carolina is seeking a Process Engineer to support cGMP manufacturing. You will join a cross‑functional team to define upstream and downstream equipment needs, qualify systems, and drive scale‑up, tech transfer, and continuous improvements.

The role requires a B.S. in chemical or biochemical engineering, 5+ years in bioprocess development or manufacturing, and strong knowledge of GMP, validation principles, and regulatory expectations.