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.

**This is a hybrid role and will require being located in the greater Seattle area to be considered.** 

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.

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 Sr. QC Data Reviewer is responsible for ensuring compliance with Fujifilm’s Quality systems, policies, and procedures in accordance with U.S. and international regulatory agencies, ICH, general cGMP, and international guidance. This role involves leading the data review process to ensure accuracy, thoroughness, and timely completion in collaboration with cross-functional departments. The incumbent must possess a strong understanding of systematic reviews and data integrity, with skills and experience in cGMP data review requiring multi-departmental collaboration.

Summary:  The Manufacturing Compliance Coordinator II assists with the tracking, coordination, and closure of Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.  

The Associate 1, Quality Control (QC) Environmental Monitoring (EM) is an entry level position responsible for performing site environmental and clean utility monitoring within the manufacturing classified areas. This role performs routine laboratory testing and support activities in continuous improvement initiatives.

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 Maintenance 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 Maintenance Technician will support Pueblo site maintenance programs, including preventative, predictive, and corrective work to ensure proper system operations. This individual will support facility-wide industrial piping, mechanical, electrical, and I&C systems by providing advanced troubleshooting and problem solving in field applications along with all other maintenance activities as assigned. Have the ability to generate NCMRs. Attend and certify as 40-hour hazwoper trained.

As a global finance business partner you will be responsible for the cost controlling and partnering of Fujifilm Biotechnologies global cost areas with a focus on IT, Quality and Science and Innovation. You will play a key role in the budgeting, forecasting, monthly reporting and financial planning processes to ensure alignment with objectives and cost optimization opportunities. In your partnering role you will collaborate and drive performance through transparency of data facilitating accountability and self-service for cost owners as well as providing guidance on governance processes.  

This position reports into the National Director of Business Development and is the primary regional point of contact for liaising with key opinion leaders in the Endoscopy space. The role of the Business Development Manager is to understand and define our internal and external endoscopic customers’ clinical needs and assist with the development and implementation of clinical studies and education solutions. Additionally, this role builds and nurtures relationships with clinical customers as it relates to participating in clinical studies and broader collaboration with the marketing organization. The incumbent is responsible for supporting the product management group including, but not limited to market research, product development, product launch, product changes, post-market surveillance, and product obsolescence.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.

Reports to                Senior Director, QA Compliance

Work Location         College Station, TX 

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 Cost Accountant!

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 Cost Accountant will be supporting cost accounting, financial reporting and analysis, month-end financial closing, and audit.

Fujifilm Sonosite’s goal is to launch the easiest to use point-of-care ultrasound (POCUS) solutions that have a reputation for reliability, while also meeting the objective of the broader business.  This role is vitally important in leading a team of product managers to advocate for our customers and ensure our product strategy comes to life.  To be successful in this role, the Sr Manager of Product Management has to be passionate about bringing products to market that delight customers and satisfy the reputation that Fujifilm Sonosite has always had around reliability, durability and ease of use while also living out all of our core values.

Summary:   Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking an eQMS Manager to lead the configuration, implementation, analysis, and maintenance of the electronic Quality Management Systems (eQMS). This role ensures compliance with cGMP, and regulatory requirements while optimizing eQMS functionality and efficiency. The ideal candidate will have strong leadership skills, technical expertise in eQMS systems, and experience with quality system validation and compliance.

Summary:

The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of regulatory submissions for national and regional regulatory agencies, and FUJIFILM Diosynth partner companies. The primary focus of this position is on moderate to complex regulatory submissions in both eCTD and non-eCTD format. Actual work assignments are based on the FUJIFILM Diosynth portfolio of work along with the incumbent's experience, knowledge, demonstrated technical skills, and competencies, or as part of an individual's development plan.

Regulatory Affairs supports all CMC regulatory affairs activities for FUJIFILM Diosynth partner companies’ products, summarize regulatory intelligence, provides CMC regulatory input for regulatory submissions, and manages the compilation and SME review of CMC sections of all submissions for completeness and quality.

Summary:

Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking Quality Assurance (QA) Validation - Associate Director to oversee the review and approval of commissioning, qualification, and validation protocols, reports, and discrepancies. This role will ensure compliance with FUJIFILM Diosynth Biotechnologies’ quality policies, site SOPs, and regulatory requirements while providing strategic leadership to the validation team.

Job Title:  Quality Assurance (QA) Validation, Associate Director

Reports to:  Director, Quality Assurance Compliance

The Senior Program Manager is responsible for leading the planning, coordination, and execution of product development projects that result in new products or feature additions or enhancements to existing products. Acts as lead with Marketing, Engineering, Operations, Sales, as well as Service to establish and manage project plans to meet commitments and company objectives.  Facilitates the resolution of conflicts in the areas of product definition, project strategy and resource deployment. Ensures compliance with established procedures for product development in a regulated environment.  Manages all Program Management trainings and execution for the global teams.

As a Clinical Engineer, you will use your ultrasound expertise and skills to identify, document, design, develop, and test point-of-care ultrasound systems, imaging, and features. You will use your knowledge, curiosity, and industry best practices to ensure Fujifilm Sonosite products are clinically diagnostic, safe, and meet user needs as you actively participate in a range of research and development activities. You will conduct extensive research and gather key data points to define clinical workflows, guide requirement development and designs, and inform current and future product development.

Being a Clinical Engineer at Fujifilm Sonosite means that you are an instrumental part of a passionate cross-functional development team. We are dedicated to creating reliable, durable, and easy to use point-of-care ultrasound systems that provide meaningful solutions to our customers.                                                                     

Summary:  Under general supervision, the Logistics Specialist I is responsible for the accurate packing, shipping, and external distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations.