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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.
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 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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Good data is the key to the future success of the company, and this role is essential to ensuring our data is the best in the industry! The Data Analyst is responsible for matching and cleaning customer data between disparate applications ensuring complete alignment to support automation projects.
The Data Operations Specialist (Temporary - 3 months) is responsible for maintaining and managing customer and item catalog data for FUJIFILM Sonosite and VisualSonics.
We have an opportunity for a dedicated team player to be a part of a fast-paced, busy manufacturing environment! Fujifilm, Sonosite, Inc is seeking Manufacturing Associates to join our team. This role has full benefits, a 401K plan, paid time off, plus more perks that come with being a full time Fujifilm Sonosite employee! As a successful candidate you will exhibit manual dexterity, reliability, basic math and computer skills and an aptitude for learning things quickly.
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 I&C Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with instrumentation and automation systems and controls across the campus. The I&C Engineer provides support for the metrology department through evaluations of instrument deficiencies, test equipment issues and calibration strategies and methods. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies.
Utility Maintenance 2 will perform corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs). Complete work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. Utilities to include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water
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