Summary:  The Quality Assurance - Compliance Specialist III - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

Who We Are

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, Arizona facility for a Process Engineer!

The Role

The Process Engineer for our Thin Films group will support manufacturing through troubleshooting and optimization of equipment and processes. They will also perform project management of capital projects, PCS / Trend review, and identify and troubleshoot issues to maintain process control.

The Manufacturing Technician II work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following: 

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 Lead Associate 2, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively trains junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.

The Lead Associate 1, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively training junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.

The Associate 1, Quality Control (QC) Microbiology is an entry level position responsible for performing routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support activities and participates in continuous improvement initiatives.

The Director of Program Design will partner with the global commercial sales team, broader commercial organization and site technical/operations teams in support of acquiring new business for Fujifilm Diosynth’s large scale cell culture sites. They will lead technical discussions with potential clients projecting Fujifilm experience and expertise in this offering. They will develop and author customer-tailored proposals and assist throughout the sales process

The Scientist 1, Global QC Analytical Development Raw Materials is responsible for coordinating the transfer of analytical methods for raw materials into the FUJIFILM Biotechnologies Diosynth Quality Control Laboratory and external contract laboratory organizations (CLOs). This role liaises with customers, CLOs, QC testing teams, and QA groups to plan and track QC raw materials readiness for clinical and commercial manufacturing, which includes ensuring
training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with all GMP (Good Manufacturing Practices)
regulatory guidelines. 

Represents Service and Technical Support for a variety of cross-functional initiatives including NPIs, reliability improvements, and product return investigations. Serviceability expert for the Sonosite product line, lending knowledge and expertise throughout the company. Provides product training to service personnel, including external biomeds. Responsible for additional duties and projects, as assigned by manager, which require a high-level understanding of products and/or processes.

The Clinical Specialist (ARDMS Certification Required) - Buffalo, 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 Albany/Syracuse/Rochester area as this would be a central location relative to the territory's business.

As a DevOps Developer III in the Software Process & Quality team of our Software Engineering department, you will create, improve, and maintain our build automation tools and infrastructure, instrumentation hooks, and other related tools needed to ensure software functionality and quality of our complex medical ultrasound device products. These works will be consumed by you, your DevOps and Software Development peers, and your Software Tester counterparts to deliver build and test results and reporting that fulfills our software test plans, verification procedures, and the overall software and system specifications. The DevOps Engineer will support the DevOps Lead to ensure reliable nightly automation runs in Jenkins against devices in our department’s Continuous Test Lab, as well as supporting local runs on developer/tester workstations. Demonstrated technical leadership in software tools and quality within Scrum/Agile teams is required. The ability to interact with cross-department counterparts and adjacent professionals from other engineering sectors is critical.

Who We Are

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 Pueblo, CO facility for a Lab Technician!

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 tier semiconductor manufacturers with a broad array of products and services used throughout the semiconductor manufacturing process.

The Role

The Lab Technician will perform sampling of finished goods, ensure correct container, dispose of waste properly, operate forklifts safely and maintain certification, properly follow repour procedures, trained and involved in site JSA process and Risk Assessment process, in addition to other particle count / sampling duties and assist in other departments, as assigned.

Summary: Laboratory Engineering Technical Support I is an entry-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 pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring. 

Under direct supervision, the Laboratory Engineer I is responsible for assisting with 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. Basic pc troubleshooting and maintenance is a plus. This position may require support outside of normal business hours.

In this position, you will gain 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, SoftMax PRO, and Unicorn.  The Laboratory Engineer I will maintain working knowledge for all such systems allowing for effective technical support. Additionally, a basic understanding of networking and Microsoft Active Directory is a plus.

The Quality Assurance (QA) Analyst III, 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.

Reports to                Director, Quality Assurance/Senior Manager, Quality Assurance

Work Location         College Station, TX (On-site at NCTM building)

Data accuracy is crucial for our company’s success, and this role is vital in ensuring our data is of the highest quality in the industry.  The Data Operations Specialist is responsible for efficiently, accurately, and promptly managing and maintaining all customer master data across our CRM and ERP systems, including data creation and modification to ensure data quality and integrity.

The Data Operations Specialist (Temporary - 3 months) is responsible for maintaining and managing customer and item catalog data for FUJIFILM Sonosite and VisualSonics.

Territory Manager - Houston - 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 office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools. 

This position requires previous capital medical equipment sales experience.

To best serve the territory, prefer candidates currently located in the Houston area