KBI Biopharma · 2 weeks ago
Engineer I, - (Downstream MS&T)
Durham, NC
Full-time
Onsite
Entry Level
$101K/yr - $139K/yr
2+ years expKBI Biopharma is a company focused on biopharmaceutical processes and manufacturing. The Engineer I role involves applying scientific and engineering principles to facilitate the transfer and enrollment of new processes into a cGMP manufacturing facility, along with supporting technical and operational decisions.
BiopharmaBiotechnologyHealth CareManufacturing
Responsibilities
Leading technical transfer projects for platform and/or repeat early-mid stage clinical manufacturing programs
Supporting business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client
Performing facility fit activities including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, and generation bill of materials (BOM) and new pacifications
Providing technical support for cGMP production runs, deviations, change controls, and CAPAs
Compiling process data and communicating out to the client and upper management via production updates and campaign summary reports
Supporting complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
Supporting collaboration on strategic projects or studies with external partners (ie. process development, vendors) and presents results in technical reports or wider industry publications
Qualification
Required
BS in Science or Engineering with minimum of 2 years industry experience or Masters without industry experience
Working knowledge of upstream and/or downstream processing techniques and equipment in biologics
Understanding GMP compliance requirements
Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production
Preferred
Experience working in a cGMP manufacturing environment
Experience with technical transfer and scale up
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 (27)
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
Peter Carbone
Chief Operating Officer
Sigma Mostafa
Chief Scientific Officer
Recent News
Kalaris Therapeutics, Inc.
2025-11-14
Company data provided by crunchbase