KBI: US - Process Engineer III

KBI Biopharma • Durham, NC

1d

About The Position

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 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 successfully 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. This may include upstream activities such as cell culture and harvest, and/or downstream processes such as chromatography, purification, and filtration. You will be at the forefront of existing best practices and evaluating technologies. Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of process equipment.

Requirements

• 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

Nice To Haves

• Experience with regulatory submissions (IND, BLA, MAA) is a plus

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 in manufacturing systems.
• Act the technical subject matter expert (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.
• As the project lead you will ensure on time 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 through the organization.
• Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.
• Perform facility fit activities for various production scenarios.
• Apply engineering principles in-order 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.
• Providing technical support for equipment modifications, deviations, change controls, and CAPAs.
• Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation.

Benefits

• challenging, rewarding and fast-paced environment
• opportunity for career advancement through the development of one’s technical skills
• collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged

What This Job Offers

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