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.

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.

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 

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.

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 quality system validation and compliance.

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 competencies, or as part of an individual's development plan.

Regulatory Affairs supports all CMC regulatory affairs activities for FUJIFILM Diosynth partner companies’ products, summarize regulatory intelligence, provides CMC regulatory input for regulatory submissions, and manages the compilation and SME review of CMC sections of all submissions for completeness and quality.

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.

Job Title:  Quality Assurance (QA) Validation, Associate Director

Reports to:  Director, Quality Assurance Compliance

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.  Manages all Program Management trainings and execution for the global teams.

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.

Being a Clinical Engineer at Fujifilm Sonosite means that you are an instrumental part of a passionate cross-functional development team. We are dedicated to creating reliable, durable, and easy to use point-of-care ultrasound systems that provide meaningful solutions to our customers.                                                                     

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.

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. 

The Lead National Support Specialist [NS3], provides an additional level of expertise and experience to the customer service national support specialists team. The Lead NS3 will assist in driving all aspects of customer support related issues, and problems, requiring escalation or high priority of each product including, but not limited to: storage, PACS, VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems for Radiology to ensure an optimal customer experience and timely resolution to high priority issues.

POSITION SUMMARY:  This position is open in our Lebanon, NH facility as an Equipment Maintenance Technician I,  II or III (level depends on experience) for our 2nd Shift 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.

The Director, Operational Excellence is responsible for driving continuous improvement initiatives and promoting Lean Sigma methodologies across the manufacturing facility. This role leads the implementation and sustainability of process improvement projects, reduce waste, optimize processes, and ensure that the facility meets its operational goals with a focus on efficiency, quality and cost reduction. This role also helps to define, establish and nurture a continuous improvement culture. This role is responsible for defining what good looks like starting with establishing the foundations of a strong program, developing and rolling out the right tools to be used, training to help all levels of the facility adopt and embed and finishing with ongoing monitoring and performance mgmt. that drives continuous improvement in to our ways of working, identifying issues and mitigating risk to drive the site to be a high performing site that is ambitious to continuously do better than yesterday. 

This position is responsible for technical repair, incoming and final quality inspection on assigned Endoscopic units for the Latin American Market. This position is responsible for consistently meeting monthly repair targets while adhering to all safety policies and procedures. This position is intended to possess the knowledge, repair skills, and expertise required to repair the most complicated endoscopes.