The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.  

The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following:

Summary: The Quality Control Project Coordinator III will construct, maintain, and oversee the Quality Control Testing Schedule to include release testing, stability testing, and method qualification activities.  The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Master Schedule to guide QC activities supporting batch release and stability testing.  The position will also require frequent communication with the...

Summary:Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering exciting summer internships for college students who have completed at least their sophomore year. We provide a...

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a Material Control Coordinator III to work in our Biotechnology Manufacturing Plant in RTP, NC. The successful candidate will be responsible for performing tasks at pre-defined levels within projects or operations.   The candidate is a competent operation professional responsible for performing tasks at...

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a Production Technician II. The successful candidate will be performing glass wash, cell culture sterilization techniques, support mammalian cell culture manufacturing processes, sustaining purification of bio-pharmaceuticals, operate various process equipment, documenting daily manufacturing operations in a cGMP environment, working with single- use and stainless steel bioreactors, fermentation, and/or filtration.  

Summary:  The Calibration Technician IV is responsible for maintaining and improving the cGMP Calibration Programs at the Fujifilm Diosynth Biotechnology Texas (FDBT) facilities in College Station Texas. This includes complex bio-pharma processing equipment such as Mobile Bio Processing Rooms, Mobile Clean Rooms, Bioreactors, Fermenters, centrifuges of various sizes and process, filtration skids, columns, critical water systems and a variety of analytical and test equipment. This is a key position in the readiness of the instrumentation and equipment for the new Texas Bio-Manufacturing Facility as...

The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications

The Utility Operator 3 will operate, maintain, and repair black and clean utility systems. This role will also be responsible for monitoring mechanical and/or electrical equipment, power distribution, chilled water, gas, domestic and de-ionized water, WFI, clean steam, boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. Also responsible for daily monitoring of tank farm, supporting lab admin building, building management system (BMS) and critical alarm response. This role will serve as primary contact and communicator to all alarms received in the control room.

The Utility Operator 3 will operate, maintain, and repair black and clean utility systems. This role will also be responsible for monitoring mechanical and/or electrical equipment, power distribution, chilled water, gas, domestic and de-ionized water, WFI, clean steam, boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. Also responsible for daily monitoring of tank farm, supporting lab admin building, building management system (BMS) and critical alarm response. This role will serve as primary contact and communicator to all alarms received in the control room.

The Director, Operational Excellence is responsible for driving continuous improvement initiatives and promoting Lean Sigma methodologies across the manufacturing facility. This role leads the implementation and sustainability of process improvement projects, reduce waste, optimize processes, and ensure that the facility meets its operational goals with a focus on efficiency, quality and cost reduction. This role also helps to define, establish and nurture a continuous improvement culture. This role is responsible for defining what good looks like starting with establishing the foundations of a strong program, developing and rolling out the right tools to be used, training to help all levels...

The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation investigations through to completion.  Support all internal and external audits.  Work collaboratively with cross functional groups including Quality Assurance to support ‘on-time’ release and disposition of batches and other post-execution activities.

The Manufacturing Technician II work directly with a range of technologies. 

The QA Specialist, Operations (Nights) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for 12-hour overnight shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that applicable DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during the shift and resolution or mitigation of issues occurring during operation.

Summary:  Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking a Document Control Manager to lead and oversee document control processes within the Quality Assurance function. This role ensures compliance with regulatory requirements, Fujifilm's quality policies, and site standard operating procedures (SOPs). The Document Control Manager will provide both strategic oversight and hands-on execution to maintain the integrity, accessibility, and organization of quality documentation, while leading a team of document control specialists.  

Summary:  The Business Intelligence Specialist is responsible for prioritizing and for hands on execution of data analytics projects and additional support of performance measures, ongoing measurement, data collection, reporting, data visualizations and information...

Summary:  The Associate Director/Program Director of Project Management Office (PMO) plays a pivotal role in strategic project and program management within the organization. This position is crucial for enhancing operational efficiencies and delivering business value,...

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.

The job holder will primarily support Project Managers and the Finance team with commercial and contract management, profitability analysis, business partnering to strategic commercial projects, pricing, and sales and operational planning.

Summary:  The Sample Management Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position works as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst I arrange sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples...