Provides field technical support for key account and/or strategic customers on all aspects of established and new products.  Visits customer sites regularly to solve problems, build relationships, understand specific support requirements, and lead application development activities.  Provides and coordinates technical training for customer personnel.  Assists Sales, Business Development, and other staff in the practical application of company products to meet customer needs.  Provides support in disseminating technical information for specific applications.  Travel will average at least 50% through serving select, top tier customers within assigned territory / region.

The Senior QC Deviation Investigator/CAPA Specialist is responsible for leading deviation investigations to ensure accurate, thorough, and on time completion.  The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation. Skills and experience must include high level complex investigations that may require global stakeholder engagement.

The QC Investigator/CAPA Specialist is responsible for supporting deviation investigations to ensure accurate, thorough, and on time completion. The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation.

The Associate Director of Quality Control Compliance is a pivotal role within the Quality Control department, responsible for ensuring adherence to quality systems and regulatory standards. This position is dedicated to overseeing key QC processes, including the lifecycle management of QC SOPs, training curricula, change control, deviation management, and data integrity. This leader will drive compliance within the Quality Control function.

As the Associate Director of Microbiology, you will play a pivotal role in overseeing all microbiological testing and ensuring the highest standards of quality, data integrity, and compliance at our manufacturing site. You will leverage your expertise to guide our efforts in maintaining a contamination-free environment, support our product pipeline, and ensure regulatory compliance.

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 Senior Automation Engineer 1, MES provides 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 will lead projects and handle complex changes while coordinating with other internal and external groups

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. 

Company Overview:

About FUJIFILM Locally: FUJIFILM Imaging Colorants, Inc. is part of FUJIFILM’s Ink Solutions Group comprised of four companies based in the UK, USA, and India. Fujifilm Imaging Colorants, Inc. has a manufacturing site in New Castle, DE where aqueous dyes, RxD, and inks are made to support the Inkjet digital printing market.

About the Global Business: Celebrating our 90th anniversary in 2024, Japan’s pioneering photographic film maker, FUJIFILM has leveraged its imaging and information technology to become a global presence known for innovation in healthcare, graphic arts, optical devices, highly functional materials, and other high technology products. We use leading-edge, proprietary technologies to provide top-quality products and services that contribute to the advancement of culture, science, technology and industry, as well as improved health and environmental protection in society. Anchored by an open, fair and clear corporate culture and with leading-edge, proprietary technologies, FUJIFILM is determined to remain a leading company by boldly taking up the challenge of developing new products and creating new value.

The Quality Control Lab Technician supports Manufacturing and various departments on site with analytical testing. The Quality Control Lab Technician is responsible for delivering analytical results within all EHS, quality, and corporate guidelines on a right-first-time basis. The position requires the ability to work rotating shifts. Technician works under the general direction of a Quality Control Shift Leader or Chemist. A wide variety of simple to highly complex laboratory tasks are conducted with a consistently high degree of independence. The position requires dependability, versatility, judgement and manipulative skill. The Technician follows all appropriate training programs, complies with all documentation requirements within the department (i.e. SOP’s, analytical logs), and effectively communicates with QC team members, supervision, and other departments. In addition, the Technician will provide direct, frontline responsibility for adherence to Quality Assurance Systems in terms of the assurance test sample program, calibration protocols, SOP’s, control limit monitoring, and all other prescribed quality initiatives.

Must be willing to work a seven-day rotating 12 hour shift schedule which may include holidays

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.