The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:

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

The QA Specialist III, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.

Reports to                Manager, QA Validation

Work Location         College Station, TX 

The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs.  The QCAT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.

The successful candidate will focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification). The role will oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for “right first time” and prolonged execution success, troubleshoot issues/spearhead investigations, and work closely with the QA group and client SMEs throughout. The candidate will also be expected to follow cGMP documentation practices and initiate deviations, lab investigations, method revisions and other related activities within the quality system.

The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. 

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 Process Engineer!

The Role

The Process Engineer for our Thin Films group will support manufacturing through troubleshooting and optimization of equipment and processes. They will also perform project management of capital projects, PCS / Trend review, and identify and troubleshoot issues to maintain process control.

The Lead Associate 1, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively training junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.

The Associate 1, Quality Control (QC) Microbiology is an entry level position responsible for performing routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support activities and participates in continuous improvement initiatives.

The Director of Program Design will partner with the global commercial sales team, broader commercial organization and site technical/operations teams in support of acquiring new business for FUJIFILM Biotechnologies large scale cell culture sites. They will lead technical discussions with potential clients projecting Fujifilm experience and expertise in this offering. They will develop and author customer-tailored proposals and assist throughout the sales process

Represents Service and Technical Support for a variety of cross-functional initiatives including NPIs, reliability improvements, and product return investigations. Serviceability expert for the Sonosite product line, lending knowledge and expertise throughout the company. Provides product training to service personnel, including external biomeds. Responsible for additional duties and projects, as assigned by manager, which require a high-level understanding of products and/or processes.

The Clinical Specialist (ARDMS Certification Required) - Buffalo, NY position is responsible for understanding and addressing the clinical needs of customers within an assigned territory.  The Clinical Specialists partner with Territory Managers to demo FUJIFILM Sonosite products, close deals, and ensure ongoing positive customer experience.  After the sale, this role owns client relationships and works to encourage customer adoption and use of FUJIFILM Sonosite products.

Note: This position is open to candidates who currently reside in the Albany/Syracuse/Rochester area as this would be a central location relative to the territory's business.

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.