The Director, Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies North Carolina sites, and globally, as needed. This role serves as the subject matter expert (SME) for regulatory practices and procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists through fostering a culture of growth and development in alignment to organizational goals while collaborating cross-functionally to drive continuous improvement and optimize Regulatory approaches.  

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

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

Position Description   We are hiring a Powder Formulation Technician. The Powder Formulation Technician will be responsible for the formulation of powdered media.   Shift: 3rd shift - 9:00PM - 5:30AM 

This position is intended to perform administrative functions, sales functions, and activities to ensure the endoscopy sales region performs optimally. Develops, directs, and manages a strategic plan for the business model to ensure the region accomplishes the business plan and achieves corporate goals. Partner with the management team to ensure the best possible service and effective communications to employees and customers.   This role will cover the western US market. The ideal candidate will reside within one of these...

Act as the local Compliance Officer for both of FUJIFILM Biotechnologies sites in North Carolina region.  In addition, they will be the main Compliance contact / support for any questions / requirements for FUJIFILM Biotechnologies.

The Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:

The Manufacturing Technician II work directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following: 

The Manufacturing Technician II work directly with a range of technologies. 

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 Quality Assurance Engineer!   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...

Business Technology & Digital Solutions is a fast-growing organization responsible for driving the digital transformation at FUJIFILM Biotechnologies. You will be surrounded by highly dedicated and skilled colleagues worldwide, all working together to ensure stable, efficient, and compliant IT solutions. The...

The Account Executive, Endoscopy is responsible for the generation of sales revenue for the organization through personal interaction with prospective customers within a given territory. This position is expected to promote the use of core products within prospective customer accounts, maintain current customer accounts to ensure a solid reference base and educate the general market on the benefits of the product. This position must establish a solid network of reference with “partner” representatives who supply the same customers with non-competitive products and...

The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and on-time commercial production. This role provides technical expertise to the immediate team and other stakeholders, as needed. Additionally, this role leads a team of Engineers and provides coaching and direction.

This position reports into the Marketing organization and manages the Interventional GI & Accessories team. The product portfolio includes innovative endoscopes for ERCP, EUS and Double Balloon Enteroscopy as well as accessories for endoscopic procedures. This role works cross-functionally both within the organization and with external stakeholders (e.g., KOLs) to execute company initiatives and manage all aspects of product commercialization, including both upstream and downstream marketing. The Senior Product Manager, Interventional GI & Accessories contributes to the evolution of the organization as new protocols and business methods gain adoption and the priorities of the division...

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 Mesa, Arizona facility for a New Product Introduction Engineer - CMP Pilot Plant!    

As the Associate Director of Microbiology, you will play a pivotal role in overseeing all microbiological testing and ensuring the highest standards of quality, data integrity, and compliance at our manufacturing site. You will leverage your expertise to guide our efforts in maintaining a contamination-free environment, support our product pipeline, and ensure regulatory compliance.

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others.  This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.  

The Automation Engineer 3, DSM Downstream 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 Downstream process areas including Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing. 

The Automation Engineer 2, DSM DeltaV Infrastructure, will provide Engineering input on the design, implementation, configuration, and testing qualification of the hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.