The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.

The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization to drive continuous improvements within the team. As member of the site Quality leadership team contribute to cohesive execution of quality initiatives and projects throughout the site in Holly Springs.

The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the GSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.

This is a remote position.  The ideal candidate is located in, or willing to relocate to, the Pittsburg, PA area.  

The Graphic Communication Division of FUJIFILM North America Corporation is the largest graphic distributor in the US. We deliver world class, state of the art solutions for Ink Jet Printing, Digital Printing, Wide Format, Offset Plates, Packaging, and a full range of traditional Offset supplies. In addition, we are the industry leader in Color Standardization and G7 implementation. 

The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the GSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.

This is a remote position.  The ideal candidate is located in, or willing to relocate to, the Akron, OH area.  

The Graphic Communication Division of FUJIFILM North America Corporation is the largest graphic distributor in the US. We deliver world class, state of the art solutions for Ink Jet Printing, Digital Printing, Wide Format, Offset Plates, Packaging, and a full range of traditional Offset supplies. In addition, we are the industry leader in Color Standardization and G7 implementation. 

The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the GSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.

This is a remote position.  The ideal candidate is located in, or willing to relocate to, the Cleveland, OH area.  

This position is responsible for technical repair and final quality inspection on assigned Endoscopic units. This position is responsible for consistently meeting monthly repair targets while adhering to all safety policies and procedures.

The Vice President (VP) of Quality Assurance (QA) is a senior leader overseeing QA functions at our Holly Springs site. This pivotal role ensures compliance with regulatory standards, drives quality initiatives, and safeguards product and process integrity. Responsibilities include strategic planning, team leadership, and cross-department collaboration to promote quality excellence.

You will develop and implement the QA strategy for Holly Springs, working closely with the site Head and global leaders to ensure consistency. A key aspect of this role is overseeing the integration and adherence to the FDB quality system, ensuring robust operational standards. This position is also accountable for delivering quality programs and projects, ensuring staff engagement, and aligning execution with customer expectations, regulatory standards, and industry best practices.

As Vice President of QA, you are also a key member of the leadership team in Global QA Operations, playing an integral role in guiding global quality strategies. A significant responsibility includes participating in the development of the global QA strategy to enhance innovative, cross-corporate streamlined quality processes. This role will have approximately 5-10 direct reports and approximately 15-30 indirect reports.

The Field Service Technician – Level 3 will report to the Regional Support Manager and will be responsible for the service and maintenance of either multiple product lines that the service team supports or a high-speed inkjet product line. This level technician will demonstrate a full working knowledge of the product lines they support including theory of operation as well as the mechanics. This position will require travel throughout the United States.

The preferred location for this position is Maryland, USA.

The Automation Engineer 3, DSM Upstream will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest. 

The Supply Chain Planner 3 role supports the project phase and operations of GMP Purchasing and Supply Chain Planning at Fujifilm Biotechnologies to ensure that the right materials are available at the right time, in the correct quantity to support process validations and GMP production. This role supports the materials planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. This role is responsible for supporting the planning team and orchestrating associated tasks to start up, while transitioning into commercial operations, including, but not limited, establishing standard operating procedure, reports, material plans, manage projects and stakeholder relationships. The role collaborates closely with all stakeholders across the Fujifilm Biotechnologies to setup accurate master data for both material and production planning in the SAP ERP system.

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.

This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required.  This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.

This role performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.   

Summary:  The Quality Assurance (QA) Compliance Specialist III – Change Control, will be responsible for supporting performance of the Quality Systems group.  The Specialist will assist with the tracking and coordination and closure Change Control records.

Reports to                Manager/Sr. Manager, Quality Assurance  

Work Location         College Station, TX 

We are hiring a Liquid Formulation Technician. The Liquid Formulation Technician will be responsible for the formulation of liquid media and diagnostic components.

Shift- 3rd shift- Midnight- 8:30 am

We have an exciting opportunity at our Mesa, AZ facility for a VMWare-Veeam Administrator!

The VMware system administrator manages FFEM’s VMware environment, including storage and network management. They design, configure, and support virtual systems. They also maintain, upgrade, and improve virtual hardware, resources, systems, and key processes.

They will manage all aspects of Veeam Backup & Replication, including creating and managing backups, recovering data, and configuring settings.

We have an exciting opportunity at our Mesa, AZ facility for an SCCM Administrator!  The System Center Configuration Manager (SCCM) administrator manages the deployment, maintenance, and updates of software, applications, and machine images across FFEM's networks. The SCCM Admin utilizes Microsoft software program SCCM to monitor, update, and secure large groups of computers across multiple domains.

Position Summary:  The Equipment Maintenance Technician opportunity is at Fujifilm Dimatix, Inc. in Lebanon, N.H.  The Equipment Maintenance Technician III is responsible for the maintenance of manufacturing equipment for production lines. Also responsible for troubleshooting and repairing downed equipment and may assist engineering staff in establishing and implementing periodic equipment maintenance. Technician may participate in safety forums, Emergency Response Teams and station improvement teams.