KBI Biopharma · 2 hours ago
Principal Process Engineer
Durham, NC
Full-time
Onsite
Lead/Staff
10+ years expKBI Biopharma is a company focused on biopharmaceutical development, and they are seeking a Principal Process Engineer to oversee manufacturing process equipment and ensure its compliance with cGMP operations. The role involves collaborating with cross-functional teams to implement new systems, improve existing processes, and lead projects related to upstream and downstream biopharmaceutical processes.
BiopharmaBiotechnologyHealth CareManufacturing
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
Qualification
Required
Bachelor's, Master's, in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field
10+ years of experience in bioprocess engineering within the biotech or biopharmaceutical industry
Company
KBI Biopharma
KBI Biopharma, Inc. (KBI) is a leading development and contract manufacturing organization serving the biopharmaceutical industry. We help
1001-5000 employees
H1B Sponsorship
KBI Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (11)
2023 (18)
2022 (26)
2021 (14)
2020 (21)
Funding
Current Stage
Late StageTotal Funding
$109.47MKey Investors
JSR
2025-10-01Corporate Round· $99.87M
2016-12-08Series Unknown
2009-09-22Series Unknown· $9.6M
Leadership Team
Marykay Marchigiani
Chief Financial Officer
Peter Carbone
Chief Operating Officer
Recent News
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2025-11-14
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