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.

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.  

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.

Summary:  Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering temporary work opportunities (20 hours per week) for current students who have completed their sophmore year 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.

We are seeking a highly motivated individual to join us as Sr. Director, Global Quality Systems and Compliance. The job holder will provide oversight and guidance to our Global Quality processes, systems and compliance activities for the Fujifilm Diosynth Biotechnologies’ growing organization. The successful candidate will lead a small global team of skilled professionals each specialising in quality critical areas which significantly impact our colleagues daily activities and our customers experience.

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.

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.

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.

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.

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. 

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.

Summary: The Technical Writer for Manufacturing Support will be primarily responsible for drafting formulation records and supporting documents for execution of manufacturing campaigns to support client needs.  Additionally, this role will be responsible for the creation and revision of Standard Operating Procedures, Work Instructions/training material and any relevant technical documentation to support manufacturing activities. This role requires an understanding of cGMP production, a strong proficiency in Microsoft Office functions, as well as an active approach to learning the latest best practices across the business.

Summary: The Microbiology IV will demonstrate a strong technical background and be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.

Summary: Our engineering team in College Station, Texas is expanding, and we are looking for a Laboratory Engineering Specialist I. Under minimal supervision the Laboratory Engineering Specialist I is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, and process development. Additional responsibilities include installation and start-up of new analytical equipment in accordance with FDBT standards and cGMP/cGLP regulatory requirements. This position may require support outside of normal business hours. This position requires a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn.  The Laboratory Engineer Specialist I will maintain working knowledge for all such systems allowing for effective technical support.

Summary: Senior Laboratory Engineer is a mid-level position in the Laboratory Engineering department of FDBT.  The primary purpose of this position is to provide day-to-day technical support for the analytical equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to implementation of new technology and equipment life cycle monitoring.  Under minimal supervision, the Senior Laboratory Engineer is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, analytical and process development. Additional responsibilities include supporting the design, procurement, installation and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. This position may require support outside of normal business hours. This position requires a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn.  The Senior Laboratory Engineer will maintain working knowledge for all such systems allowing for effective technical support.

The Automation IT Engineer,OpIT (Operations Information Technology) is an entry level up to 6 years’ experience position in the OpIT Engineering group of FDBU.

Summary: The Quality Assurance (QA) Risk Management Manager position will be responsible for providing leadership to the Texas site in ICH Q9 principles of Risk Management.  Ability to facilitate risk assessments, train future facilitators, provide oversight and tracking of remediation actions, and communicate to leadership on the status.

Summary: FUJIFILM Diosynth Biotechnologies Texas is seeking a dynamic and dedicated MSATPrincipal Scientist to fulfill the leadership role of the Process Characterization (PC) Unit as part of the Process Development team at the College Station, Texas site. This person will lead a growing team of talented scientists and work directly with counterparts within the FDB global organization to deliver on an expanding globally harmonized PC business model. The PC laboratories will include state of the art instrumentation to support late-stage process characterization activities for biopharmaceutical programs for external sponsors. It is preferred to find a candidate with exposure to upstream, downstream, and analytical biopharmaceutical development and process characterization.   (Relocation assistance provided)

Summary: The Quality Assurance – Sr. Compliance Specialist, 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, investigations, and all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.   

Summary: The Senior Quality Assurance (QA) Analyst, 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. They will also provide daily guidance, work prioritization and support to other departments, such as manufacturing or QC, in absence of or in conjunction with their manager.