KBI: US - Process Engineer III

KBI:

US - Process Engineer III KBI Biopharma - 2.6 Durham, NC Job Details Full-time 1 day ago Qualifications Quality control corrective actions FDA submissions Chemical Engineering Requirements specification Cell culture Technical documentation Design of manufacturing processes Engineering Equipment installation Engineering process optimization Project timeline management Corrective and preventive actions (CAPA) Biochemical Engineering Industrial equipment troubleshooting Manufacturing standard operating procedures Chromatography Bachelor's degree Continuous improvement Scientific protocols Requirements analysis Pharmaceutical plant experience Experimental design Bachelor's degree in chemical engineering Regulatory submissions Commissioning phase involvement Root cause analysis Senior level Cross-functional collaboration Project leadership Cross-functional team management Full Job Description Principal Process Engineer Job Description 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. Key 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 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. 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.

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 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. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.