The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation investigations through to completion.  Support all internal and external audits.  Work collaboratively with cross functional groups including Quality Assurance to support ‘on-time’ release and disposition of batches and other post-execution activities.

Summary: The Manufacturing Compliance Coordinator I leads 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 Weigh and Dispense Associate 1 is responsible for assisting with and executing the set-up, weighing of raw materials, solvents, and solutions. This role interacts with both Drug Substance and Drug Product teams as well as Warehouse for commercial operations and tech transfer activities required from the Weigh and Dispense operations. This role is responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed. The Weigh and Dispense Associate 1 is required to work shiftwork, including nights and on-call.

The Supervisor, Facilities Maintenance Services under the supervision of the Manager Facility Maintenance Services will be responsible for maintaining, administering and improving the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of the Texas operations. Primary responsibilities include managing the daily maintenance operations including the CCMS/CMMS administration, the work order lifecycle process, the Planning & Scheduling of Maintenance and Calibration activities, and the MRO inventory across multiple facilities.

This position with assigned personnel and/or contractors will be responsible for the oversight of the maintenance support operations through strict adherence to Standard Operating Procedures (SOPs) and cGMPs in a Pharmaceutical Manufacturing Facility. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance and calibrations technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance operational activities of FDBT. Also, this position should ensure that departmental milestones and goals are met in accordance to the approved plans and budgets.

The Planner/Scheduler for Calibration under the supervision of the Supervisor for Maintenance Services is responsible for the planning, scheduling and performance of the calibration program including the oversight of the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such supporting Texas operations. Primary responsibilities include managing the daily calibration operations such as screening of incoming work orders, identification of job requirements, scheduling of calibration staff.  This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, maintenance technicians, validation, quality and external suppliers in order to provide a high level of excellence over the calibration operational activities of FDBT.

The Associate Planner for Facilities, under the supervision of the Supervisor Maintenance Services, or designated supervisor will be responsible for performing various aspects of Facility Services and coordination of Work order support for the Texas campus. Primary responsibilities include various aspects to support facilities with planning and scheduling equipment for biotech processing equipment. This position will require the use of technical manuals, on-line resources and OEM representatives to maintain the equipment. Strict adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory.

This person will be a member of the Sustaining Development Team.  They would work on a combination patches and hotfixes to support our product suite.  The test engineer will do manual and tool assisted testing of patches and hotfixes.  The test engineer will participate in our daily scrum as well as other team scrums to stay aware of overall application changes. 

The Technical Support Engineer, MI – II (Tier II) handles remote technical support across our product lines for HCUS customers. The expectation of the position is to be versed in primary support across our Synapse products, and the ability to support more complex issues. This engineer must be comfortable with making decisions while working on these more complex issues. This role requires a firm grasp of time management and organizational skills. To meet the needs of our customers, working outside normal business hours and on some weekends/holidays is required. In addition to working OT to handle workload and meet required metrics/expectations.

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.

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 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. 

As part of our Global Finance team, you’ll partner with senior leaders, playing a critical role in our growth journey. You will have a comprehensive understanding of all the services offerings of our business, the markets in which we operate and our asset capabilities and profitability. This role focuses on partnering with global functions to evaluate new investment opportunities, whether through growth or acquisition. You will build financial models, challenge assumptions, develop scenarios with an understanding of risks, and enhance financial awareness and influence decisions to achieve four times revenue growth by 2030.   

The Customer Support Technician – Remote Support will be responsible for providing technical support advice and consultation to Fujifilm clients via phone, on-line or other methods.  Travel approximately 15% required for training and development for in house or OTJ opportunities.

The Business Innovation 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, Toner, 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 FUJIFILM Disoynth Biotechnologies (FDB) Group consist of 6 separate entities with different history and way of workings. The entities are located in US, UK and Denmark. The FDB Group has a common goal of having a global tax strategy and tax policies. 

In this role, you’ll shape the Groups tax strategy and be a part of our Global Central Finance team.  You will develop and oversee the Group’s Global Tax Strategy, ensuring compliance with international tax laws and  ensuring an efficient tax position for the Group across all jurisdictions.  

The Senior Manufacturing Project Lead will lead and organize manufacturing projects and support activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

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.

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 Warehouse 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 Warehouse Technician will ship and receive hazardous chemicals according to all quality and ISO 45001, 9001 standards, and by following all DOT and CFR49 requirements.

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.