Summary: Laboratory Engineering Technical Support I is an entry-level position in the Laboratory Engineering department of FDBT.  The primary purpose of this position is to provide day-to-day technical support for the analytical pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring. 

Under direct supervision, the Laboratory Engineer I is responsible for assisting with the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, analytical, and process development. Additional responsibilities include supporting the design, procurement, installation, and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. Basic pc troubleshooting and maintenance is a plus. This position may require support outside of normal business hours.

In this position, you will gain a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftMax PRO, and Unicorn.  The Laboratory Engineer I will maintain working knowledge for all such systems allowing for effective technical support. Additionally, a basic understanding of networking and Microsoft Active Directory is a plus.

Territory Manager - Houston - Remote

As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment.  This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools. 

This position requires previous capital medical equipment sales experience.

To best serve the territory, prefer candidates currently located in the Houston area

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.

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.

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.

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 

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.

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.

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.

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 an Operations 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

Our Pueblo, CO facility is seeking a motivated self-starter to join our team on the chemical production line. This individual is responsible for manufacturing our high purity chemicals that are used in the semi-conductor industry. If you are looking for a new opportunity, please apply today!

Summary:

The QC Stability Coordinator I, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.

The Quality Control Coordinator I, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee scheduling the stability testing and compiling data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

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.