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Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Quality Assurance – Sr. Compliance Specialist – Audit and Inspection, will support all associated audit responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary The Quality Control Cell Biology III will be responsible for assisting in the qualification of test methods for in-process and final products. Be able to work under minimal supervision. Perform advanced assays requiring precise analytical skills and understanding of cell biology and immunology principles.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Microbiology Analyst III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Microbiology Analyst II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Microbiology Analyst I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The CAPEX Project Coordinator, under the supervision of the Associate Director of Project Engineering and Capital Projects, will be responsible for the support of capital projects documentation through the management of initiation and close out documents, schedule tracking, and multi-departmental approval routing.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Quality Assurance (QA) Specialist of compliance, will be responsible for supporting performance of the Quality Systems group. The Specialist will assist with the tracking and coordination and closure Change Control records.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary The Cell Biology Analyst II will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary:
The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: 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.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
SUMMARY The Senior Validation Engineer, under minimal supervision, will be responsible for drafting and executing utility, process systems and process support systems qualification test work across multiple GMP facilities as well as support cleaning and process validation when necessary. Preparing validation summary reports for the qualification and validation of systems used to manufacture drug or biologics products.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols for facilities, utilities, manufacturing equipment and quality control equipment, as well as preparing validation final reports for the same.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary:
The Senior Scientist in the Analytical Development, Cell based assay Group is primarily involved in the development, establishment, qualification and validation of cell-based analytical methods. The Senior Scientist is responsible for designing, planning, executing and interpreting complex laboratory experiments and development activities within established timelines.
The Senior Scientist in the Cell based assay group is also responsible for creating method qualification/validation protocols and summary reports, executing protocols, reviewing data, ensuring a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshooting issues/spearheading investigations and working closely with the QC group and client.
The individual should possess broad scientific knowledge of cell culture and bioanalytical techniques that are used to characterize viruses and proteins as well as strong technical writing skills. The individual will lead internal and client-based projects and is expected to supervise junior scientists, stay abreast of new technologies, regulatory requirements and quality standards related to the area of analytical method development and validation. The candidate will be expected to follow cGMP documentation practices.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Computer System Validation (CSV) Engineer III, under general direction, will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Computer System Validation (CSV) Senior Engineer, under general direction, will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Validation Project Manager will be responsible for managing the execution of multiple validation related projects at FDB Texas facilities.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The Validation Manager will be responsible for management, scheduling and/or hands on drafting and executing of qualification/requalification of Facilities, Utilities, System and Equipment (FUSE) for one of the 4 Manufacturing Buildings (NCTM, TBF-100, FBF-200, FBF-300). The Validation Manager will be responsible for updating the corresponding manufacturing building’s Systems Master List, Requalification Schedule, and management of Validation Engineers/Specialists for day-to-day validation activities.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering part time work (10-20 hours per week) for college students majoring in Life Sciences or preferably Biological Sciences. We offer a supportive, collaborative teaching environment to develop our student worker’s skills and identify their career goals. This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization. The student worker will work in direct contact with the department staff to assist with department specific duties as requested. The duration of the position will be determined between the supervisor, and Human Resources.
Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
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.
Summary: The QC Chemist – Raw Materials I, under direct supervision, will be responsible for assisting with raw material sampling, managing quarantine materials and prepare sample shipments for contract laboratory testing. They will also assist with supporting the Quality Control department in the release of all raw materials from the Quarantine Cage/Area for use in Non-GMP and GMP manufacturing activities for NCTM and TBF-100.
Other responsibilities may include but are not limited to: Filing folders, Managing SAP for material accountability at TBF-100 and at NCTM, ordering materials for sampling, coordinating with Materials Management/Warehouse Department on release of components and chemicals, and acquiring BSE/TSE, OAF, USP Class VI statements and/or applicable documents from vendors.