KBI
KBI: US - Process Engineer III
USA - NC - Durham - National Way · Mid
Sponsorship not specifiedDetected 30 days ago
Project ManagementCustomer SupportGMPFDA RegulatoryCRISPRCell CultureLeadershipCommunicationCollaborationProblem SolvingFermentation
About the role
- 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.
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.
- 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
- 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
Requirements
- 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
- 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.
Nice to have
- Experience with regulatory submissions (IND, BLA, MAA) is a plus
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.