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Search Results Page 7 of 14

Job Locations US-TX-College Station
Posted Date 2 months ago(4/19/2022 9:27 AM)
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.
Requisition ID
2022-19620
Job Locations US-TX-College Station
Posted Date 2 months ago(4/19/2022 9:27 AM)
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.  
Requisition ID
2022-19619
Job Locations US-TX-College Station
Posted Date 2 months ago(4/19/2022 9:28 AM)
Summary:  The 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.
Requisition ID
2022-19618
Job Locations US-TX-College Station
Posted Date 2 months ago(4/19/2022 9:28 AM)
Summary:  The 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.  
Requisition ID
2022-19617
Job Locations US-TX-College Station
Posted Date 2 months ago(4/19/2022 9:29 AM)
Summary:  The Engineering Coordinator, under the supervision of the Director of Engineering, will be responsible for performing engineering coordination activities on behalf of the different facilities at Fujifilm Diosynth Biotechnology Texas (FDBT) and the projects implementation under the engineering department responsibility. These activities include but are not limited to tracking and review projects and engineering documentation, coordinating construction activities and/or equipment installations, coordinating with impacted areas for activities implementation, performing asset inductions, support work order generation and documentation and preparing project updates, status and/or metrics. This position will work closely with project/process engineers, CAPEX team, manufacturing resources, validation and contractors to help coordinate engineering activities in support of project’s implementation and/or utility/process equipment complex operational issues. This position will also support P&ID development/redlining, and maintenance strategies development.
Requisition ID
2022-19616
Job Locations US-TX-College Station
Posted Date 3 months ago(3/30/2022 6:03 PM)
Summary:  Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering temporary work opportunities (40 hours per week) for current or recent Graduates in Life Sciences or related fields.  We offer a supportive, collaborative environment that encourages development of necessary skills, identify, and attain career goals.  This is a great opportunity to gain invaluable experience working for an industry-leading biopharmaceutical contract manufacturing organization.  The position offers prospects of working experienced scientific personnel on key projects.  The duration of the position can be discussed with the supervisor and Human Resources. The temporary position also offers possibilities of translating into a full-time position within Fujifilm Diosynth.
Requisition ID
2022-19564
Job Locations US-TX-College Station
Posted Date 2 weeks ago(6/17/2022 11:31 AM)
Summary: The QC Stability Coordinator Lead, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Stability Coordinator Lead, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.  
Requisition ID
2022-19513
Job Locations US-TX-College Station
Posted Date 3 months ago(3/24/2022 4:57 PM)
Summary: The QC Stability Coordinator III, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.
Requisition ID
2022-19512
Job Locations US-TX-College Station
Posted Date 3 months ago(3/24/2022 4:55 PM)
Summary: The QC Stability Coordinator II will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Coordinator II, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.
Requisition ID
2022-19511
Job Locations US-TX-College Station
Posted Date 3 months ago(3/24/2022 4:53 PM)
Summary: The QC Stability Coordinator I, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.  The Quality Control Coordinator I, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee scheduling the stability testing and compiling data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.
Requisition ID
2022-19510
Job Locations US-NC-Research Triangle Park
Posted Date 1 week ago(6/20/2022 3:54 PM)
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re 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. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
Requisition ID
2022-19503
Job Locations US-TX-College Station
Posted Date 3 months ago(3/25/2022 3:53 PM)
Summary:  The CAD & Engineering Document Management Specialist, under the supervision of the Director of Engineering, will be responsible to proactively develop the computer aided design function and properly define the engineering document management strategy for the College Station site. Perform routine to moderately complex design and drafting functions in support of various areas such as engineering, manufacturing, facilities, validation, etc. Perform various aspects of maintaining the engineering drawings, blueprints, P&IDs, technical manuals and other documents related to the equipment and facilities of FDBT, both hard copy and electronic.    Responsibilities include verification of existing equipment and facilities documents in cooperation with contractors, engineers and validation personnel, and tracking the changes made to those documents under authorized engineering change control. This will include facilities drawings, OEM and Vendor drawings, and producing revisions to such drawings. This will also include drafting preliminary changes to such drawings for approvals, as well as tracking drawings which are out-of-date and no longer accurate or obsolete. This position will also be responsible for working with engineers and equipment providers of utilities and equipment OEMs for up-to-date versions for turnover.    Primarily be responsible for FDBT facilities and equipment documentation but the role may include GMP facilities and equipment not wholly owned by FDBT and will require liaison with engineers or document control personnel of other contractors and institutions.  This position will also work closely with other technicians and engineers who need access to the most recent documentation, such as Validation and Quality personnel.  
Requisition ID
2022-19472
Job Locations US-NC-Research Triangle Park
Posted Date 3 months ago(3/18/2022 10:59 AM)
The Fujifilm Diosynth Biotechnologies, USA Analytical Development group is seeking a skilled bioassay lab scientist to fill an exciting role as Scientist II located at the Bioprocess Innovation Center in Morrisville, North Carolina. 
Requisition ID
2022-19468
Job Locations US-TX-College Station
Posted Date 3 months ago(3/17/2022 11:49 AM)
Summary:  The Manufacturing Support Scheduler/Planner leads  the creation and maintenance of the short-term Weigh and Dispense and Formulation schedule for all FDBT Manufacturing areas to support the Manufacturing Master Schedule.  The Scheduler/Planner reviews production schedules for opportunities and adjustments based operational capacity, room availability, supplies, delivery dates to manufacturing and sample submission and testing.  Clear concise updates on the schedule changes are required, and are tailored to the audience (internal customers such as Weigh and Dispense, Solution Prep, Central Services (Cleaning),  Maintenance, Quality, Planning and Manufacturing).
Requisition ID
2022-19461
Job Locations US-NC-Holly Springs
Posted Date 3 months ago(3/15/2022 11:35 PM)
We are looking for a Pharmaceutical Quality System (PQS) Manager, who 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. As the PQS Manager for the site, you will have direct impact on establishing the PQS of a $2 billion Greenfield CDMO facility.   In the project phase, your main responsibility as the PQS Manager will be to establish PQS in accordance with ICHQ10 and cGMP guidelines. Provide Quality Assurance partnership with global quality partners, site management and SMEs to establish an efficient and effective cGMP compliant PQS. You will partner with other areas within the project, as well as QA departments at other FujiFilm sites to leverage existing PQS systems, processes, procedures, and documents, where possible, to provide efficient, effective, agile, and aligned QA PQS strategies and procedures.   Once in operations, you will lead a team of QA PQS SME’s responsible for ensuring that systems and processes are maintained in a compliant state throughout product lifecycle, with a focus on consistent operational monitoring (performance indicators) and continuous improvement. Additionally, you will lead and participate in client audits and regulatory agency inspections.  
Requisition ID
2022-19443
Job Locations US-NC-Holly Springs
Posted Date 1 week ago(6/20/2022 4:11 PM)
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 manufacture 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 we call Genki. We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.  The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. You as the process equipment engineer will ensure that the process equipment deliverables from Fujifilm and from the EPCM provider are timely and in the required quality. You will act as driver of the process equipment activities and must be able to proactively facilitate cross organizational interaction with external EPCM providers and use your extensive experience from a similar role in large pharma/biotech projects. 
Requisition ID
2022-19442
Job Locations US-TX-College Station
Posted Date 4 months ago(3/15/2022 5:40 PM)
Summary:  The Staging Coordinator will support the FDBT Manufacturing Team by performing tasks associated with receiving picks, inventory management and/or distribution of BOM, non-BOM, gowning and cleaning materials delivered to the manufacturing staging area. The role is responsible for adherence to current Good Manufacturing Practices (cGMP's), operating Powered Industrial Vehicles (PIV’s), safe handling of chemicals and weighted material, use of validated computer systems, ability to accurately complete documentation, make calculations, and perform physical tasks associated with large scale pharmaceutical manufacturing. The role may be cross trained to support other areas including weighing of raw materials, picking material at the Warehouse and/or issuing material.
Requisition ID
2022-19439
Job Locations US
Posted Date 3 weeks ago(6/8/2022 1:34 PM)
The Director, Business Development (internally known as Commercial Development Manager) will identify, manage the initial qualification, and close through the signing of a contract for new business, concentrating on Biologics. This candidate will be remote and should be located in the eastern US. 
Requisition ID
2022-19395
Job Locations US-TX-College Station
Posted Date 4 months ago(3/14/2022 9:27 AM)
Summary:     The Scientist I in the Analytical Development (VAD) is primarily involved in the development, establishment, qualification, and validation of analytical ultracentrifugation (AUC) and analytical methods. The Scientist I is responsible for planning, designing, executing, and interpreting complex laboratory AUC and analytical experiments and development activities within established timelines with broad priorities set by AD leadership to achieve project goals.   The key individual will be responsible for characterization and testing of viral vector-based gene therapy products, and recombinant protein therapeutics through analytical ultracentrifugation (AUC) as well as perform a suite of analytical and biophysical assays to accommodate rapidly changing priorities while delivering high-quality results. Troubleshoot issues/spearhead the investigations and work closely with Process Development groups and clients.   The individual should possess broad scientific knowledge of bioanalytical techniques and cell culture that are used to characterize viruses and proteins as well as strong communication and technical writing skills. The individual will lead internal and client-based projects, stay abreast of new technologies, regulatory requirements, and quality standards related to the area of analytical method development with AUC centric. The candidate will be expected to follow good cGMP, lab, and documentation practices.
Requisition ID
2022-19392
Job Locations US-TX-College Station
Posted Date 2 months ago(5/2/2022 12:05 PM)
Summary:  The Deviation Coordinator I is responsible for supporting deviation investigations to ensure accurate, thorough, and on time completion.  The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation.
Requisition ID
2022-19365