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 customer’s headquarters staff, store management, field service, and product teams. They will ensure quality service delivery that meets service levels and improves equipment uptime while maintaining high customer satisfaction. This role also supports the sales team by identifying and supporting service revenue opportunities within the account.

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 collaborates with cross-functional teams to drive continuous improvement and optimize CQV practices.

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 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 business needs and priorities. You will ensure ongoing alignment with FDB IT strategy, portfolio and capacity. The role is vital for FDB IT to succeed as a global organization. 

You will provide guidance on FDB IT’s governance model and aid in formalizing, prioritizing, and documenting business cases and monitor customer and tech trends impacting service provision. 

As a global finance business partner you will be responsible for the cost controlling and partnering of FDB 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.  

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 research, product development, product launch, product changes, post-market surveillance, and product obsolescence.

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 

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 supportive and collaborative teaching environment to help interns develop their skills and pinpoint their career goals. This opportunity offers invaluable experience with an industry-leading biopharmaceutical contract development manufacturing organization. Interns will work under the guidance of a department manager on a project focused on enhancing current processes and improving efficiency. Internships typically run from mid-May to August, with specific dates determined collaboratively between the intern, their supervisor, and Human Resources. 

A validation intern's key objective is to support documentation, testing, compliance, project activities, and process improvement efforts within the validation department. 

Start Date: This internship is set to begin on May 19th, 2025 for an 11-week duration ending on August 8th 2025. 

Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided. 

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.

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 required to fulfill on-call responsibilities, as needed.

The working hours for this position are 10AM-6:30PM.