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The purpose of this role is to provide customer support of Fujifilm ES equipment in the Endoscopy department and/or specified departments by managing all relevant equipment, providing basic trouble shooting, and training for proper care and handling of our equipment. This role provides onsite, hands-on client support for Fujifilm Endoscopy’s entire product catalog. This role provides education and training to Company personnel and customers. This position reports directly to the Regional Sales Manager or Zone Sales Director and is the primary sales support resource for the Company and its sales team.
The Warehouse Assistant will be responsible for all Warehouse daily activities related to Receiving, Put away, Returns, Picking, Shipping, Housekeeping and all SAP transactions to close and directly reporting to the Warehouse Manager. The Warehouse Assistant will report all issues related to the daily activities to the Warehouse Floor Supervisor.
Summary: The Maintenance Technician I, under the supervision of the Facilities Maintenance Supervisor, or designated supervisor will be responsible for performing various aspects of utilities, facilities and process equipment maintenance and support for the FDBT site buildings.
Primary responsibilities include various aspects of maintenance and support for facilities, utility equipment and biotech processing equipment. This position will be required to use technical manuals, on-line resources and OEM representatives to maintain the equipment operational with a minimum of downtime. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory
The Manager, CSV will be responsible for management, scheduling, and 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 at each of our 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. They 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.
Manufacturing Associate (1st Shift, Transducers) - Bothell, WA
This position is responsible for performing a variety of tasks associated with manufacturing diagnostic ultrasound transducers. Specific tasks may include some of the following:
The Associate Manager of Instrumentation & Controls (I&C) ensures the efficiency and operational reliability of the site instruments through an effective calibration process. This role sets the direction and manages the development of the I&C team as the site transitions from construction to operations. Additionally, this role assists with establishing efficient programs designed fit for future operations by utilizing current Good Manufacturing Practice (cGMP) / Good Laboratory Practice (GLP) knowledge, work scheduling, instrument calibration, repair, and troubleshooting. This role also provides day-to-day oversight and development of the I&C team.
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.
Reports to Supervisor/Manager, QA
Work Location College Station, TX
Summary: The Calibration Technician I 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.
The Clinical Specialist (ARDMS Certification Required) - Boston, MA position is responsible for understanding and addressing the clinical needs of customers within an assigned territory. The Clinical Specialists partner with Territory Managers to demo FUJIFILM Sonosite products, close deals, and ensure ongoing positive customer experience. After the sale, this role owns client relationships and works to encourage customer adoption and use of FUJIFILM Sonosite products.
Note: This position is open to candidates who currently reside in the Boston area as this would be a central location relative to the territory's business.
The Manager of Environment, Health & Safety (EHS) will lead EHS and sustainability programs at the New Castle facility, driving improved performance through implementing EHS programs, ensuring KPIs are met and investigating all incidents /near miss. The position will also be responsible to ensure all environmental and compliance requirements for the facility are met. The position is also responsible to lead the safety committee and delivering all relevant training for the employees. This site is ISO 14000 certified.
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.
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Quality Control Chemist I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.
The Quality Control Chemist III, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Quality Control Laboratory. Following Tech-Transfer Activities, the candidate will be responsible for performing in-process, release and stability testing using the established analytical methods.
Summary: The Validation Engineer II, under moderate supervision, will be responsible for drafting System Impact Assessments (SIAs), drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing validation final reports for the same.
Summary: The Manufacturing Readiness Coordinator I assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.
This position is intended to serve as a member of the Escalation team, researching complex issues for a leading medical software company. The role investigates issues by analyzing problems and exploring the baseline program to determine the root cause, leading to resolution. It will encompass both the system environment and the software application, so the escalation engineer will need to be familiar with Windows Server environments, as well as capable of learning the application and troubleshooting it.
FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity for a Maintenance Technician I at our Hollister, CA facility!
The Role
As a Maintenance Technician I, you will be responsible for performing mechanical maintenance and installations for manufacturing, cleanroom, lab, and facilities. These activities include items such as: repair and installation of plant piping systems, repair and installation of packaging/conveyor systems, general utility repairs.
This person will also be involved in day-to-day maintenance activities to include completion of work orders, electrical motor change outs, and preventative maintenance tasks. Hours worked may vary based on business need (i.e. to maintain production schedule, emergencies, etc.).
The Senior Technical Clinical Consultant, Cardiology shall be responsible for all aspects of the reporting design and build, configuration, workflow, measurement/data mapping for project and or post go-live support cases in compliance with the company’s quality procedures.
The Manufacturing Technician II works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:
We are hiring a Part Time (20 hours per week) General Laboratory Specialist. The General Laboratory Specialist will be responsible for cleaning of laboratory floors, glassware and laboratory cabinet wipe down (Counter tops are the responsibility of the scientists).
Part time: Morning 8-12 or 9 -1 M-F
Position Description - Manufacturing Quality Engineer II for FUJIFILM Dimatix, Inc, Lebanon, NH.
Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products. Plan, implement, and manage compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures. Review nonconformities and works with Supplier Quality Engineering to coordinate supplier corrective actions. Lead Internal Corrective Action Request (ICAR). Minimize product quality risk. Drive continuous improvement in product designs and manufacturing processes. Partner with key individuals to identify opportunities for continuous improvement through testing and analysis of manufacturing process data. Work with cross-functional teams to analyze and resolve any issues arising from Manufacturing Process, Engineering Review Board (ERB), or Material Review Board (MRB). Perform process statistical analysis. Manage multiple continuous improvement projects simultaneously. Implement statistical modeling using Minitab. Perform manufacturing-related data analysis and related distributions. Employ MRB and ERB reviews. Utilize manufacturing quality tools including FMEA, DFMEA, PFMEA, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC. Apply international quality system standards including ISO 9001.
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