FUJIFILM

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Search Results Page 8 of 11

Job Locations US-TX-College Station
Posted Date 11 months ago(1/4/2022 12:52 PM)
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.  
Requisition ID
2021-16645
Job Locations US-TX-College Station
Posted Date 11 months ago(1/4/2022 12:52 PM)
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.
Requisition ID
2021-16636
Job Locations US-TX-College Station
Posted Date 7 months ago(5/10/2022 1:53 PM)
Summary:  The Program Manager, with mentoring and support from the Head of Program Management and/or Associate Program Director or Program Director, will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to program delivery including technology transfer and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure.  The Program Manager ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).  The Program manager typically manages programs of shorter duration and/or fewer concurrent programs relative to a Associate Program Director.  
Requisition ID
2021-16630
Job Locations US-TX-College Station
Posted Date 1 month ago(10/26/2022 6:25 AM)
Summary: The Calibration Technician II 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.
Requisition ID
2021-16627
Job Locations US-TX-College Station
Posted Date 2 months ago(10/12/2022 3:56 PM)
Summary: The Calibration Supervisor oversees the cGMP Calibration Program at the Fujifilm Diosynth Biotechnology facilities in College Station Texas, including both research and production facilities. The Supervisor initiates, implements, and schedules the calibration of instruments and devices in the facility with an emphasis on planning and scheduling calibration through the use of technicians, and outside resources and vendors.   The Supervisor prepares SOPs and calibration instructions for the new instruments entering the system, the periodic calibration of those instruments during their life cycle, and the proper documentation when those instruments and devices may either fail calibration, or be retired from the system.  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 to enable the company to meet the expectations of our clients.  
Requisition ID
2021-16328
Job Locations US-TX-College Station
Posted Date 1 year ago(9/24/2021 1:04 PM)
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.
Requisition ID
2021-16179
Job Locations US-TX-College Station
Posted Date 1 year ago(9/24/2021 12:12 PM)
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.
Requisition ID
2021-16178
Job Locations US-TX-College Station
Posted Date 1 year ago(9/22/2021 4:37 PM)
Summary:  Our Capital Project team in College Station, Texas is expanding and we are looking for a Project Engineer to ensure deliverables for his/her respective projects are well managed and in line with their stakeholders and company expectations. We are looking for a Project Engineer who can help to plan projects and establish the criteria by which project success will be measured. The successful candidate will be responsible for establishing project inspection criteria, coordinating the review of project designs and ensuring the proper implantation of project elements. 
Requisition ID
2021-16156
Job Locations US-TX-College Station
Posted Date 1 year ago(9/22/2021 4:26 PM)
Summary: The CAPEX Project Coordinator, under the supervision of the Director of Engineering and Technology, 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. 
Requisition ID
2021-16154
Job Locations US-TX-College Station
Posted Date 2 months ago(10/10/2022 12:30 PM)
Summary: The Sample Management Tech 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 with the Sample Management team to manage the samples received from manufacturing for QC testing and the organization and inventory of these samples. The Sample Management Technician also arranges sample shipments for outsource testing and shipments to Clients or other facilities. 
Requisition ID
2021-16142
Job Locations US-TX-College Station
Posted Date 1 year ago(10/18/2021 5:00 PM)
Summary:  The Senior Automation Engineer provides technical support and accountability for the execution of capital projects that are critical to the success of our business. The Senior Automation Engineer will participate in the development, installation, operation, maintenance, and repair of all FUJIFILM Diosynth Biotechnologies Texas automation systems to meet organizational goals and objectives.This position will also work closely with other operators, calibration technicians and engineers to maintain complex systems.
Requisition ID
2021-16102
Job Locations US-TX-College Station
Posted Date 9 months ago(3/15/2022 3:08 PM)
Summary: The Manufacturing Process Engineer I position is an integral part of the Manufacturing Technical Operations department, supporting Gene Therapy manufacturing at the National Center for Therapeutics Manufacturing (NCTM) and the Flexible BioManufacturing Facility (FBF200), located in College Station, Texas.  This position will report directly to the Manager of Technical Operations, Gene Therapy Manufacturing.   Works independently, and with colleagues, to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of a variety of gene therapy, protein, and other types of drug substances.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit.  Operational biotechnologies include:  Isolators and biosafety cabinets and their use in cell propagation, Cell Culture/Single Use Technology for adherent and suspension culture, Dispensing and Mixing and Buffer Preparation, Chromatography, Tangential Flow Filtration, various filtration technologies, cCentrifugation, and Bulk Fill.  This position will also create training programs and perform training for manufacturing technicians in the unit operation categories.
Requisition ID
2021-16100
Job Locations US-TX-College Station
Posted Date 1 year ago(9/13/2021 9:33 AM)
Summary:  The Associate Director, Upstream Process Development, functions independently and productively in the Upstream Process Development Group actively engaged in process development within a team based PD laboratory to support a wide variety of vaccine development projects. The individual should display strong technical knowledge and scientific understanding of cell and virus culture, expansion, harvest, medium development, clone selection and development, and DOE studies, as well as having experience in process development with both small and large process scales for vaccine development. The individual will provide significant scientific and technical contributions within the Process Development Group and will work closely with the customer to develop strong working relationships.
Requisition ID
2021-16041
Job Locations US-TX-College Station
Posted Date 12 months ago(12/7/2021 3:22 PM)
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.
Requisition ID
2021-16013
Job Locations US-TX-College Station
Posted Date 1 year ago(9/7/2021 6:18 PM)
At FDB, your passion – your Genki – is your power. Here, your passions will be recognized, nurtured, fueled, and celebrated by those around you. Join FDB and join other motivated individuals who fuel one another’s passions and embrace every day as an opportunity for impact where we know it matters most: human lives. Advance tomorrow’s medicines with us!   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.
Requisition ID
2021-15997
Job Locations US-TX-College Station
Posted Date 1 year ago(9/7/2021 6:08 PM)
At FDB, your passion – your Genki – is your power. Here, your passions will be recognized, nurtured, fueled, and celebrated by those around you. Join FDB and join other motivated individuals who fuel one another’s passions and embrace every day as an opportunity for impact where we know it matters most: human lives. Advance tomorrow’s medicines with us!   Summary: The Computer System Validation (CSV) Senior Engineer, under general direction, willbe 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.
Requisition ID
2021-15996
Job Locations US-TX-College Station
Posted Date 1 year ago(9/7/2021 1:49 PM)
At FDB, your passion – your Genki – is your power. Here, your passions will be recognized, nurtured, fueled, and celebrated by those around you. Join FDB and join other motivated individuals who fuel one another’s passions and embrace every day as an opportunity for impact where we know it matters most: human lives. Advance tomorrow’s medicines with us!   Summary: The Validation Project Manager will be responsible for managing the execution of multiple validation related projects at FDB Texas facilities.
Requisition ID
2021-15988
Job Locations US-TX-College Station
Posted Date 1 year ago(9/7/2021 12:42 PM)
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.
Requisition ID
2021-15985
Job Locations US-TX-College Station
Posted Date 4 months ago(8/2/2022 11:36 AM)
Summary:  The electronic Quality Management System (eQMS) Systems Administrator will be the Quality organization's Subject Matter Expert (SME) as it relates to the configuration, implementation, analysis as well as the maintenance of the (eQMS) across multiple FDB facilities.
Requisition ID
2021-15828
Job Locations US-TX-College Station
Posted Date 2 months ago(10/5/2022 11:12 AM)
Summary:The Calibration Planner/Scheduler under the supervision of the Facilities Support Supervisor is responsible for the planning, scheduling and performance of the calibration program including the oversight of the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such as the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility (FBF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT).Primary responsibilities include managing the daily calibration operations such as screening of incoming work orders, identification of job requirements, scheduling of calibration staff. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance technicians, validation, quality and external suppliers in order to provide a high level of excellence over the calibration operational activities of FDBT
Requisition ID
2021-15792