KBI: US - Process Engineer III

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, is seeking a highly skilled Process Engineer to support cGMP operations, ensuring that manufacturing process equipment is maintained and optimized. The Process Engineer will lead projects that improve current processes and implement new processing equipment while ensuring compliance with all regulations.

The ideal candidate has a Bachelor's in chemical engineering and over 10 years of experience in bioprocess development. Strong communication and problem-solving skills are essential, along with expertise in biologics and process optimization.

Qualifications

• 10+ years of experience in bioprocess development or manufacturing within biotech.
• Expertise in biologics, cell therapy, gene therapy.
• Strong understanding of cGMP regulations and FDA/EMA guidelines.

Responsibilities

• Support equipment commissioning and qualification activities.
• Collaborate to troubleshoot and resolve equipment-related issues.
• Lead projects to improve manufacturing operations.
• Design and execute experiments for process optimization.

Skills

Bioprocess development

Manufacturing

Project management

Communication

Problem-solving

Education

Bachelor's in chemical engineering

Tools

Process modeling tools

Job description

Process Engineer

Process Engineering is responsible for all manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations. As a Process Engineer, you will act as a member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to define upstream and downstream process equipment requirements, specifications and standards for facility fit, and assess equipment design and operation in a commercial cGMP production facility.

Key Responsibilities

• 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.
• Act as the technical subject matter expert (SME) for upstream and/or downstream equipment and the site clean utilities, ensuring proper installation, qualification, and maintenance.
• Lead process engineering related projects to improve manufacturing operations or implement new processing equipment, ensuring timely delivery, compliance with project requirements, and project budget.
• 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 throughout the organization.
• Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with others.
• Perform facility fit activities for various production scenarios.
• Apply engineering principles to problem solve and drive projects to successful completion within defined timelines.
• Manage multiple concurrent projects and resources.
• Lead and support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
• Provide technical support for equipment modifications, deviations, change controls, and CAPAs.
• Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation.

Qualifications

• Bachelor's in chemical engineering, biochemical engineering, or related field.
• 10+ 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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.