Manufacturing Sciences Engineer II

KBI Biopharma•Durham, NC

2d•Onsite

About The Position

The Upstream MS&T Engineer II will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes leading technical transfer projects for platform and/or repeat clinical manufacturing programs, supporting and/or driving business decisions and operations related to facility fit, time in plant and new technologies or equipment, and communicating recommendations to the client. The role also involves performing facility fit activities such as process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generating bill of materials (BOM) and new item specifications. Additionally, the engineer will provide technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls, and supervisory and technical support during technical document execution, new equipment testing, and water runs in manufacturing. The position requires compiling and analyzing process data, communicating findings to the client and upper management via production updates and campaign summary reports, and supporting/leading complex investigational and troubleshooting efforts. Collaboration on strategic projects or studies with external partners and presenting results in technical reports is also part of the role.

Requirements

BS in Science or Engineering with minimum of 4 years industry experience, Master’s with 2 years industry experience or PhD with no years industry experience
Expertise in upstream and/or downstream processing techniques and equipment in biologics
Experience with technical transfer and scale up is required
Experience with GMP compliance requirements
Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production
Strong proficiency in English and overall communication is required
Strong engineering and scientific reasoning skills are required
Strong math skills are required
Strong computers skills are required particularly in all MS Office programs
Some equipment operations and testing is required

Nice To Haves

Experience working in a cGMP manufacturing environment is preferred

Responsibilities

Leading technical transfer projects for platform and/or repeat clinical manufacturing programs
Supporting and/or driving 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, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications
Providing technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls
Providing supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs
Providing supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing
Compiling/Collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports
Supporting/leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
Supporting/leading collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports
Apply engineering principles in-order to problem solve and drive projects to successful completion within defined timelines
Manage multiple projects and resources
Work independently and with teams
Possess excellent communication skills