Process Sciences Sr. Engineer

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki. 

 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

Summary:  The Senior Engineer functions independently and productively within a team based organization to actively address complex cGMP manufacturing issues.  The individual is responsible for analyzing process technologies in support of new project proposals and takes responsibility for the technical transfer into the manufacturing group for Clinical and/or Commercial. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment. 

External US

Essential Functions:   

• Applies scientific and cGMP manufacturing expertise to research and resolve issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines. 

• Leads multiple overlapping cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Will also be responsible for assisting other teams as SME.   

• Research and recommend single-use process equipment of appropriate scale and quality for the cGMP execution of client specified manufacturing processes. 

• Responsible for the preparation of user requirements, vendor quotes, and purchasing of equipment as well as supporting capital projects by providing technical expertise. 

• Oversees and leads small complex engineering projects. 

• Assist in overseeing contractor activities, as required. 

• Provides technical information for the preparation of change controls, protocols, and new user training for the process equipment. 

• Reviews process requirements for GMP manufacturing through process specifications and batch records. 

• Identifies raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes; assists in the preparation of material specifications, vendor quotes, and the purchase of the materials. 

• Responds to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures.  

• Uses key and critical process parameters and their associated critical quality attributes to assist in the preparation of product specifications. 

• Provides data analysis from each manufacturing run that will be included in intermediate and final project summary reports and other team deliverables.  

• Contributes to and ensures the achievement of goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources.   

• Perform all other duties as assigned. 

 

Required Knowledge/Technical Expertise 

Individual will have knowledge/expertise relevant to: 

• supporting  single-use equipment and systems such as: 

• Fermentation and Cell Culture reactors  

• GE AKTA chromatography systems supported by Unicorn software 

• Tangential Flow Filtration Systems 

• Depth Filtration systems 

• Working within cGMP environments in relation to biologics and vaccine manufacturing. 

• Process development or manufacturing experience with clinical scale projects. 

• Single-use manufacturing equipment and materials. 

• Understanding and experience in aseptic techniques. 

• Document writing including protocols, batch records, and SOPs and summary reports. 

• Using Microsoft Excel, Word, and PowerPoint. 

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