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The Regulatory Affairs Specialist II is responsible for supporting the Regulatory Intelligence deliverables, the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Biotechnologies partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format and working with site functional groups with their response to changes in relevant Regulatory Intelligence. Actual work assignments are based on the FUJIFILM Biotechnologies portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's development...
The HL7 Integration Engineer (IE) for Canadian region oversees all technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in general and clinical environment workflow. In addition to technical expertise, HCUS relies on HL7 IE to deliver industry leading customer satisfaction, requiring excellent communication and verbal skills within project teams and externally with customers.
The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.
The QA Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues. This role works 12-hour day shift on a 2-2-3 cadence, 0600-1800.
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 at our North Kingstown, RI facility for a Controller!
With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top...
At Fujifilm Sonosite, we are looking for an experienced Sr. Compliance Engineer who will be responsible for providing global product compliance analysis and guidance to ensure that all electrical, mechanical and other regulated performance specifications are satisfied in all countries where Fujifilm Sonosite’s business exists or will expand. You will be part of a Regulatory Compliance team that conducts global due diligence for product compliance requirements, monitors emerging regulations and new standards, develops compliance specifications and policies, builds compliance programs to support Fujifilm Sonosite’s business initiatives, and troubleshoots...
This position is responsible for Toner Digital Press equipment and workflow solution sale for both new business and existing accounts in an assigned region.
This sales position covers our service areas in Northern IL (Chicago)/southern Wisconsin (Milwaukee) and Minnesota (Minneapolis). The ideal candidate would be in the Chicago region.
As an FPGA Engineer III, you will be responsible for implementing innovative FPGA solutions that enable Fujifilm Sonosite ultrasound systems to meet real world clinical needs. You will work with a diverse group of talented engineers from Electrical, Systems, Ultrasound, and Software teams to design the next generation of ultrasound systems using the latest FPGA technologies, FPGA design processes, and tools, from product conception all the way to production. You will have the opportunity to lead projects where you will need to interact with external experts and vendors to understand, integrate and implement new enabling technologies. To be successful in this...
As a Senior Electrical Engineer, you will be responsible for the development of clinical ultrasound systems. This role will provide project leadership and electrical design through all development stages, including requirements definition, architectural design, circuit design, layout, bring-up, system integration, test, debug and verification. You will be a subject matter expert (SME) with strong working knowledge of analog, digital, signal processing and low-noise subsystem design. This role requires familiarity with all aspects of the system level design including the analog front-end, A/D acquisition, digital signal processing and imaging functions....
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 at our Mesa, AZ facility for a CMP Technical Marketing Manager!
With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the...
The QA Engineer, Learning Management System (LMS) is responsible for collaborating alongside team members in the creation of curriculum, serving as a ComplianceWire Administrator, assisting in the continual development of FUJIFILM Diosynth Biotechnologies' education program. This role adheres to Good Manufacturing Practices (GMP) to ensure compliance with applicable legislation. The QA Engineer, LMS acts as a site ambassador to encourage, motivate, and assist in meeting deliverables and timelines. This role works closely with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency across the network and drives continuous improvements for the area.
The Engineer or Scientist 3, Material Science supports the design and development of new single-use consumables in conjunction with our manufacturing teams. This role supports the leachable and extractables program, including organizing testing and creating a data library based on products evaluated. This role also supports manufacturing investigations involving items such as: raw material variability and concerns, consumable issues, particle sources, and provides impact assessments in collaboration with other MSAT subject matter experts (SMEs). Additionally, this role writes investigation reports and leachable and extractable reports. The technical specialist is the SME for customer and regulatory audits and articulates the Fujifilm Biotechnologies procedures,...
The FUJIFILM Integrated Inkjet Solution (FIIS) Global Sales Director is responsible for developing and executing the worldwide sales strategy for FIIS to drive profitable revenue growth, expand market presence, and strengthen customer relationships across diverse international markets. This leadership role involves directing sales teams, cultivating strategic partnerships, and aligning sales initiatives with overall business objectives to achieve outstanding results in a competitive global environment.
The Senior Reliability Engineer is responsible for life cycle asset management. This role monitors equipment performance and identifies and mitigates issues related to system and equipment reliability. Additionally, this role works with the Plant Engineering team to develop maintenance strategies to optimize equipment performance. This role functions as a maintenance lead in root cause analysis, analyzing equipment failures, and creating predictive forecasts for system optimization.
The Planner 2, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role uses knowledge of maintenance processes and regulatory requirements to plan, schedule, and coordinate maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role seeks opportunities for continuous improvement and collaborates cross-functionally to ensure successful completion of maintenance activities.
The Planner 1, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role plans, schedules, and coordinates maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role collaborates with departments across the site to ensure successful completion of work orders.
The Manager, Training & Documentation for Manufacturing Support is responsible for leading the training and documentation team, focusing on the development, implementation, and oversight of comprehensive digital learning programs. This role enhances employee skills, drives organizational performance, and supports the company's digital transformation initiatives in drug substance manufacturing. The Manager, Training & Documentation designs...
The Director at Fujifilm Biotechnologies Texas (FLBT) plays a crucial role under the guidance of the Vice President of Engineering and will provide technical and process ownership for all aspects of clinical and commercial parenteral drug product manufacturing operations. Leadership and subject matter expertise is required in new technology introduction, equipment selection/qualification, technology transfer, process validation, scale-up, process monitoring, troubleshooting and continuous improvement. Collaboration with local and global departments is vital for overall...
Territory Manager - Michigan West - Remote
As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment. This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician...
The Automation Engineer 1, Building Management System (BMS) provides support to the entire facility ensuring efficiency and reliability of the automated systems that monitor and control environmental conditions and utility production. This role supports senior engineers with the implementation of changes to the automation systems, execution of testing and troubleshooting events, and provides on-call support, as needed. Initially, this role supports the expansion project for the facility with the scope evolving as the project progresses.