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.

We are hiring a Field Applications Scientist Intern. The Field Applications Scientist Intern will work with the Life Sciences Field Applications Team to lean existing processes and help drive project goals to completion.

Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking a Document Control Supervisor to lead and oversee document control processes within the Quality Assurance function. This role ensures compliance with regulatory requirements, Fujifilm's quality policies, and site standard operating procedures (SOPs). The Document Control Supervisor will provide leadership, oversight, and hands-on execution to maintain the integrity, accessibility, and organization of quality documentation, while leading a team of both contract and full-time document control specialists.

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 QA Specialist, LMS is responsible for collaborating alongside current team members with the creation of curriculum, serving as ComplianceWire administrator, assisting in the continual development of FUJIFILM Diosynth Biotechnologies' education program, co-developer of internal PQS SharePoint site, overall site training ambassador to help encourage, motivating and assisting in meeting deliverables and timelines and more. Works closely with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency.

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 Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following:

The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer

Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in

these production process units.

The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units.

The Manufacturing Director is responsible for the planning, directing, and coordinating activities related to the manufacturing processes for TBF/FBF building while maintaining a highly effective operation leading to the production of safe, efficacious and compliant monoclonal antibodies and therapeutics. The Manufacturing Director will be responsible for the cGMP production, manufacturing and systems that support the manufacture of monoclonal antibodies or virus-related vaccines and biotherapeutic products in a BSL 2 state-of-art facility.

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