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...

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

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...

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.

The Associate Director of Commissioning, Qualification, and Validation (CQV) is responsible for leading and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate Director, CQV...

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.,...

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...

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.  

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...

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...

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...

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.  

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. ...

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.  

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.

The Senior Director of Capital & Engineering Procurement is responsible for developing a strategic, integrated approach to Capital Expenditure (Capex) and Engineering procurement, optimized for business value and savings, and achieved through strategic planning and external spend management. The role will develop and implement policies and procedures for the procurement of services, materials, equipment related to large capital projects, for the establishment and management of strategic procurement agreements and to support annual CapEx budgeting processes. 

Fujifilm Diosynth Biotechnologies U.S.A., Inc. is seeking a Production Technician II. The successful candidate will be performing glass wash, cell culture sterilization techniques, support mammalian cell culture manufacturing processes, sustaining purification of bio-pharmaceuticals, operate various process equipment, documenting daily manufacturing operations in a cGMP environment, working with single- use and stainless steel bioreactors, fermentation, and/or filtration.  This will be a first shift role 7am-7pm.