The QC Data Reviewer plays a vital role in Quality control group and 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 Senior Project Manager is responsible for leading and executing strategic projects within the site, ensuring alignment with organizational goals and regulatory standards. This role involves managing multiple projects from inception to completion, optimizing project delivery, and fostering cross-functional collaboration to achieve business objectives.

An Imaging Service Engineer II is responsible for performing scheduled and unscheduled service work on systems within a service area as directed by the Area Service Manager.

The Computer System Validation (CSV) Engineer III, under general direction, will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.

We are hiring a Sr. Validations Engineer. The Sr. Validations Engineer will be responsible for performing validation activities related to processes, equipment, test methods, computerized systems, and facilities.

The Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry, QC Bioassay, QC Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.

The Automation Engineer 3 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 leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection.

The Microbiology III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Diosynth Biotechnologies Texas (FDBT) Quality Control Laboratory.

Summary:   

The Fixed Assets Accountant is responsible for overseeing the accounting, reporting and analysis of fixed assets. This role requires to be highly organized, with a solid technical accounting knowledge base and excellent communication skills. The position involves successfully handling multiple projects with established timelines while ensuring audit readiness. 

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 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 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 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 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.