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.  

We are hiring for a National Account Support Manager which  is responsible for the strategic oversight of service for assigned accounts and overall customer satisfaction. This role includes developing and implementing consistent account management processes across all accounts, focusing on equipment performance, service level attainment, reporting, communication, and meeting structures. The position entails detailed analysis, program creation, and implementation to achieve desired results. The National Account Support Manager will build long-term relationships with the...

The Manufacturing Support Associate 3 plays a crucial role in maintaining compliant and reliable production, with adhering to cGMP regulations and industry guidelines. This position leads compliance initiatives, oversees corrective and preventive action (CAPA) execution, and coordinates batch planning, all while ensuring seamless tech transfer and effective troubleshooting as a process subject matter expert (SME). The role demands flexibility in working hours to effectively support 24/7 production and accommodate inspections and audits.

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 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.,...

As the IT Business Partner, you will drive the collaboration with business units to ensure IT aligns with local needs, serving as the primary contact for FUJIFILM Diosynth Biotechnologies (FDB) Global IT. You will drive the collaboration with Site leadership, FDB IT Functional areas, and Project Management to ensure seamless alignment with...

As a global finance businesspartner you will be responsible for the cost controlling and partnering of FDB global cost areas

Under general direction, the HR Associate will be responsible for coordinating the onboarding and orientation process for all employees and contractors hired at site.  The HR Associate will also help drive HR programs that focus on employees.  The successful individual in this role will ensure all the necessary actions behind the scenes are executed so that employees feel a seamless experience with the HR function.

The Client Coordinator Administrative Assistant will provide comprehensive assistance and support to the program management team as well as facilitating client-facing site visits and coordinating internal and external events. This role is key to ensuring smooth operations and exceptional client interactions while supporting client-facing teams in significant matters requiring their attention.

The Senior Investigator of Deviations Management for Drug Product Finished Goods (DPFG) is responsible to complete major and complex manufacturing investigations, identify root cause, and create effective corrective and preventive actions (CAPAs). This role engages with regulatory inspectors, internal auditors, and senior leadership, as needed regarding the findings of investigations. Additionally, this role mentors and provides guidance to junior investigators throughout the investigation process.

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...

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...

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.  

Summary:Fujifilm Diosynth Biotechnologies, Texas, Inc. is offering exciting summer internships for college students who have completed at least their sophomore year. We provide a...

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...

We are hiring a Compliance Manager to be a member of the FUJIFILM Holdings America Corporation Compliance Department. The Compliance Manager will conduct day-to-day management of compliance activities for FUJIFILM North America Corporation to ensure ongoing corporate compliance with internal and external standards.   Our ideal candidate would reside in the Eastern US.  

The Warehouse Associate 1 position is responsible for storage, handling, and distribution of materials and products. This role supports Warehouse operations in receiving, shipping, and/or logistics. The Warehouse Associate 1 works with multiple functions to support operations (e.g., Manufacturing, Quality, Process Sciences, and other customers). This role uses SAP ERP system for inventory management, cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs). This role requires shift work and/or weekend hours to support operations and is