Join FUJIFILM Diosynth Biotechnologies (FDB) in our new facility location - Thousand Oaks, California (FDBC)! The IT Business Analyst, QC/PD LIMS will serve as a liaison between business and technology to assist or gather business requirements needed for the Laboratory Information Management Systems (LIMS). This person will be the subject matter expert and lead for all applications for the Quality Control (QC) and Process Development (PD) department and report to the IT Applications Lead. In addition, this person will lead multiple initiatives for these systems in alignment with the Global FDB IT organization.

Join FUJIFILM Diosynth Biotechnologies (FDB) in our new facility location - Thousand Oaks, California (FDBC)! The IT Business Analyst, Quality Management Systems (QMS) will serve as a liaison between business and technology to assist or gather business requirements needed for the Quality Management Systems (QMS). This person will be the subject matter expert and lead for all applications for the Quality department and report to the IT Applications Lead. In addition, this person will lead multiple initiatives for these systems in alignment with the Global FDB IT organization.

Summary: LDO MX electronic batch record platform will be implemented across FDBK, FDBT and FDBU. The LDO MX Site Business Process Lead will lead the day-to-day management of LDO MX, working in cross functional teams both sitewide and globally.  The Site BP Lead should have a broad knowledge of GMP prep, manufacturing execution and QA activities in relation to batch records, to help make informed decisions.  This position will own the business processes associated with the LDO MX platform, tracking and communication of data and KPIs associated with project goals (reduce disposition time by 50% and GDP errors by 80%).  They will also collaborate with the Master Control MX teams to influence their roadmap; own the LDO SOPs, WIs and eLearning material; and partake in the global LDO committee to promote and ensure alignment across sites.

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a Material Control Coordinator, Warehouse Sampling I/II 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 predefined levels within projects or operations. Tasks may be routine in nature, expertise is generally limited to areas of responsibility. The candidate understands the “why” part of the job and demonstrates knowledge of internal customers and support area requirements.

Summary:  The Sr. Process Engineering Manager, under the supervision of the Director of Engineering, will be responsible for leading a team and overseeing process engineering activities such as new equipment/systems installation, new products introduction support, infrastructure assessments, system capability assessments, troubleshooting support and technical expertise for process equipment and site utilities on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Equipment support includes bioreactors, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam/water boilers, water purification and distillation units, wastewater treatment systems, among others. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC and contractors to perform projects implementation and to help maintain complex process equipment and site utilities. This position will require involvement in the utilities and production processes to identify and implement process improvements using Change Control procedures as well as perform corrective and preventive actions using the CAPA system. This position will provide guidance on P&ID development, maintenance strategies development, SOP’s development and equipment commissioning/qualification activities as required. This position will also lead the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects.  

Summary:  The Process Engineering Manager, under the supervision of the Director of Engineering, will be responsible for leading a team and overseeing process engineering activities such as new equipment/systems installation, new products introduction support, infrastructure assessments, system capability assessments, troubleshooting support and technical expertise for process equipment and site utilities on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Equipment support includes bioreactors, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam/water boilers, water purification and distillation units, wastewater treatment systems, among others. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC and contractors to perform projects implementation and to help maintain complex process equipment and site utilities. This position will require involvement in the utilities and production processes to identify and implement process improvements using Change Control procedures as well as perform corrective and preventive actions using the CAPA system. This position will provide guidance on P&ID development, maintenance strategies development, SOP’s development and equipment commissioning/qualification activities as required. This position will also lead the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects.  

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Associate Director, Supplier Quality will report directly to the VP of Quality at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for the supplier quality process and program. They will lead the Supplier Quality Team and define the Supplier Quality Plan strategy.

Summary The Quality Control Cell Biology Supervisor will be responsible for coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing.  The Cell Biology/Immunology Supervisor will lead tech transfer activities of qualified cell based and immunological methods from designated donor laboratories.  The Supervisor will play a pivotal role in selecting qualified personnel to staff the QC Cell Biology laboratory.  

Fujifilm Diosynth Biotechnologies Texas, LLC Senior Scientist – Downstream Process Development College Station, Texas  

Summary:  The Manufacturing Compliance Coordinator II assists with the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.  

Summary:  The Manufacturing Compliance Coordinator I leads the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.

Summary:  The role of Site Head, Biologics Program Management is to lead the local Program Management team: - Sponsor and direct program delivery at Fujifilm Diosynth Biotechnologies to deliver on the commitments made to our customers and provide outstanding customer service. - Lead the site S&OP process to ensure that the site delivery plans are aligned with the budget, that the resource and asset strategies of the business are based on forecasts of customer demand while pro-actively identifying and mitigating risks.   No matter what role you play in FUJIFILM Diosynth Biotechnologies (“FDB”), you are part of a team that is having a profound impact on the lives of countless individuals and families across the globe.  The manufacturing processes that we develop and the medicines that we produce help protect, improve, extend, and save lives. We recognize that to maximize our impact and ensure the success of our customers and therefore the success of FDB, we need to build a diverse team of individuals that are driven by a passion that we call “Genki.”  Genki is personal, it’s your driving force to learn, grow, strive to do better, and strive to be better knowing that your work truly is positively impacting the lives of countless others around the world.   FDB is a Contract Development and Manufacturing Organization (“CDMO”) with the sole purpose to support our customers as they deliver on the medicines of today and advance the medicines of the tomorrow. The Program Management team are critical to the successful delivery of our customer’s programs and therefore the success of FDB through careful coordination and management of the vast resources across the FDB network including incredibly talented subject matter experts that each contribute to delivering on our commitments to our customers to advance tomorrow’s medicines.

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Control Specialist/Senior Specialist will report directly to the Senior Manager, Quality Control at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for planning and implementing the design, configuration and/or customization of LIMS according to business requirements . They will lead optimization of LIMS activities in collaboration with functional areas, which include defining LIMS workflows, maintain dynamic/static data in LIMS, perform and participate in GMP review, LIMS Access review and internal/external audits.

Summary:  The Validation Project Manager will be responsible for managing the execution of multiple Computer Systems validation (CSV) and Data Integrity (DI) related projects at FDBT facilities. Support the Director of Validation by ensuring effective implementation and maintenance of the CSV and DI program. Serve as a CSV subject matter expert, and track and report action plan status/ completion as relates to CSV/DI validation systems improvement efforts.

Summary:  As part of the Human Resources team, the Talent Acquisition Specialist will be responsible for supporting the staffing efforts of Fujifilm Diosynth Biotechnologies Texas, LLC (FDBT) and building a strong technical workforce that adds to the company’s bottom line. This highly skilled technical recruiting professional should possess knowledge of employment and labor law, have a deep understanding of the organization and its staffing needs, and possess strong interpersonal and communication skills. The Talent Acquisition Specialist must be able to match candidate talents and qualifications for specific jobs in the biotechnology field by screening them and recommend them for placement. The process of recruiting may involve both internal and external sourcing methods, thereby requiring the Talent Acquisition Specialist to be adept at understanding where and how to locate candidates.

Summary:  The Information Technology Quality Engineer serves as the IT Administrator for Quality and/or Laboratory Information Systems.

We are looking for a CIP & Clean Utilities Process DeltaV Automation Engineerwho wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. In the project phase, your main responsibility as the CIP & Clean Utilities Process DeltaV Automation Engineerwill be to provide Engineering input on the design and implementation of an Emerson DeltaV control system in the areas of Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system for the defined process areas. You will report to the Automation Lead for DSM.

The Senior Cleaning Validation Engineer is a high-level position in the MT&S department of FDBU. In this position you will provide on the floor support developing automation methods, working directly with clients, working with chromatography/filtration systems and acting as the Subject matter expert for the role. 

Summary:  The Sr. Project Engineer, under the supervision of the Director of Engineering, will be responsible for leading, preparing, coordinating and monitoring the implementation of the assigned engineering projects including the development of any specifications and infrastructure requirements, discussion with A&E firms, project documentation review, contractors and/or vendor coordination, field progress inspection and project closeout documentation on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Assigned projects may be related to new product introductions, local capital projects and/or strategic projects as dictated by the business needs. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC, contractors and other functional areas to execute and document the projects Change Controls procedures as the main system for documenting changes to the facility, utility and/or equipment as applicable. This position will also support P&IDs development, maintenance strategies development, SOP’s development and equipment commissioning/qualification activities as required.

Summary:  The Sr. Process Engineer, under the supervision of the Director of Engineering, will be responsible for performing engineering activities, new equipment/systems installation, new products introduction support, infrastructure assessments, troubleshooting support and technical expertise for process equipment and site utilities on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT). Equipment support includes bioreactors, incubators, filtration skids, chromatography skids, centrifuge, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, air cooled chillers, air compressors and dryers, air handling units, MCRs, MBUs, steam/water boilers, water purification and distillation units, wastewater treatment systems, among others. This position will work closely with facilities, manufacturing resources, CAPEX team, validation, QA/QC and contractors to perform projects implementation and to help maintain complex process equipment and site utilities. This position will require involvement in the utilities and production processes to identify and implement process improvements using Change Control procedures as well as perform corrective and preventive actions using the CAPA system. This position will also support P&ID development, maintenance strategies development, SOP’s development and equipment commissioning/qualification activities as required. This position will also lead the identification of equipment of the proper type, size, materials, throughput, physical dimensions, required utilities and URS development for future projects.