Summary:  The Sample Management Analyst 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 as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst I arrange sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples for QC testing.   

We have an exciting opportunity at our Mesa, Arizona facility for a QC Chemist!  The QC Chemist serves as a Quality Control Specialist responsible for analyzing semiconductor materials in support of product qualification and to support all Quality Control laboratory processes.

The Reprocessing Engineer I is responsible for ensuring that Fujifilm Sonosite medical devices and accessories are designed to be cleaned and disinfected by customers in the field. This role operates within the Systems Engineering team and interfaces with specialists within the Hardware Verification, Mechanical Engineering, Product Management, and Clinical Engineering teams. This role will combine biology, chemistry, materials science, clinical workflows, and industry standards to develop well-established safe and effective disinfection procedures for medical ultrasound devices. The Reprocessing Engineer I will also provide guidance and leadership in the realm of sustainability, ensuring that FUJIFILM products are designed with materials and processes that have minimal impact on the environment.

The Sr. Analyst 1, QC Analytical Development (AD) Chemistry works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Sr. Analyst 1, QC AD Chemistry adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and authors and reviews procedures, SOPs, and technical reports.

The Sr. Analyst 1, QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). This role supports the transfer and validation of methods such as residuals (HCP, DNA, Protein A), dot blot for product identity, ELISA ID/ Potency and various cell-based assays. The Sr. Analyst 1, QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and author and review procedures, SOPs, and technical reports.

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

The Supervisor, Weigh & Dispense is responsible for leading the Weigh & Dispense team and operations within Supply Chain to ensure compliant and reliable production. This position works closely with Raw Material Sampling to flex resources between Weigh & Dispense and Raw Material Sampling, optimizing staffing and productivity. The Weigh & Dispense team consists of multiple shifts in which this supervisor leads and oversees to support the demands of the production schedule, including night shifts, as needed.

The Senior Supply Chain Analyst role supports Supply Planning and Warehouse. Using both soft and technical skills, the analyst role works cross functionally with other areas (e.g., Manufacturing, Quality, and Process Science) to analyze data for future improvement and cost analysis. This role is both tactical and transformational by initiating, preparing and facilitating initiatives to build a strong Supply Chain for the future. The Senior Supply Chain Analyst contributes to establishing KPls and ensures transparent, unambiguous visual and verbal communication to drive optimization of stock levels for both cost and availability to support warehouse and production capacity.

The Quality Assurance (QA) Manager, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies.  The Manager will handle all associated responsibilities in compliance with FUJIFILM Biotechnologies quality policies and site SOPs to ensure regulatory compliance. 

Reports to                Director, QA Compliance

Work Location         College Station, TX 

The Production Scheduler, Drug Product Finished Goods is responsible for creating, maintaining, and optimizing daily and long-term production schedules across drug product manufacturing, filling, inspection, and packaging operations. This role ensures timely product delivery and efficient use of resources while adhering to current Good Manufacturing Practices (cGMP). Acting as a central coordination point, the scheduler partners with other departments (e.g., Manufacturing, Planning, Quality, Supply Chain) to align material availability, equipment capacity, and staffing needs with the production plan.

Regional Sales Manager - North East - Remote

This position is responsible for meeting the monthly, quarterly, and annual regional sales quota. Provide direction and leadership for regional sales team. Direct management responsibility for sales Territory Managers, including performance management, skill development, coaching and mentoring of sales technique and territory management.

This position requires previous capital medical equipment sales experience.

To best serve the territory, prefer candidates currently located in the North East US area

The Clinical Specialist (RDCS Certification Preferred) - Manhattan, NY 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 Manhattan, NY area as this would be a central location relative to the territory's business.

We are hiring a Senior Counsel to be an integral part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas Corporation and FUJIFILM SonoSite, Inc., wholly-owned subsidiaries of FUJIFILM Holdings America Corporation (HLUS). The Senior Counsel, reporting to the Division General Counsel, Medical Devices, will be an experienced commercial transactions lawyer, responsible for working independently and collaboratively on legal issues affecting the Medical Device businesses to minimize risks of legal liability and ensure maximum legal rights of the company. The right candidate will be excited to join a growing company with a diverse portfolio of businesses. This attorney will be a senior legal resource and valued business partner for HLUS and its Medical Device businesses.

Please include cover letter and resume indicating your interest and expertise in this position.

This position is intended to develop the next-generation of automated testing and will have the responsibility to supervise automation development and manage a team of software test automation engineers as various experience levels.

Position Description

We are hiring a Document Control Manager. The Document Control Manager will manage Document Control personnel and related systems.  They will provide guidance and supervision of Document Control functions, which include the creation, revision, approval, maintenance and issuing/printing of product labels, SOP’s, posters, forms and other controlled documents.  They will also manage training recording and comprehension verification and be in charge of the development, maintenance and implementation of electronic document management system improvements and revisions.

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.  Responsibilities include providing technical leadership on major projects and resolving complex technical challenges for ultrasound applications in an FDA regulated environment.  You will work cross-functionally with adjacent groups such as mechanical engineering, experience design, and software development. Experience and knowledge in leading complex products through the product development process is critical to success. This is an opportunity to take a product through the end-to-end development lifecycle, from inception through design, development, testing, deployment and support.  In this role you will lead board & system level electrical development, with the opportunity to drive innovation and influence the value & quality of our products.  Come help us enable medical professionals to quickly image, triage and treat medical conditions which change lives for patients.

The Sr. IT Engineer 1 is responsible for the support and operation of all IT network infrastructure for the new Holly Springs greenfield site. The engineer will also liaise with Global IT teams to ensure a fit-for-purpose network architecture scaled for a large manufacturing plant. This role functions as a local extension of the Global IT team reporting into the Sr. Director - IT. This role ensures local implementation and support in alignment with global IT processes.

The Sr. IT Engineer 1 is responsible for the support and operation of all IT platform infrastructure for the new Holly Springs greenfield site. The engineer will also liaise with Global IT teams to ensure a fit-for-purpose network architecture scaled for a large manufacturing plant. This role functions as a local extension of the Global IT team reporting into the Sr. Director - IT. This role ensures local implementation and support in alignment with global IT processes.