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The Lead Associate 3, 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 trains 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.
Shift: Monday – Friday (8am – 5pm)
The Supervisor, QC Microbiology leads a team of microbiology analysts to execute GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing. This role ensures cGMP compliance, data integrity, safety, and right first-time performance, while driving method robustness, investigation quality, and continuous improvement. The Supervisor typically supervises staff and junior scientists, manages day-to-day operations, and contributes to cross functional initiatives of moderate complexity.
Shift: Wednesday – Saturday (7am – 5pm)
The Quality Control group at FDBU group is seeking a Lead QC Associate II – Raw Materials at our Bioprocess Innovation Center in Morrisville, NC. The QC Lead Associate II is responsible for sampling, testing, and releasing incoming raw materials in compliance with GMP, regulatory standards (USP/EP/JP), and internal quality procedures. This role ensures materials meet specifications prior to use in manufacturing and supports data integrity, documentation, and continuous improvement within the Quality Control laboratory.
Shift: Monday – Friday (8am – 5pm)
The Senior QA Engineer, Validation helps drive the Quality oversight for Commissioning, Qualification, and Validation (CQV) processes. The position also oversees, reviews, and approves QA validation activities and documents associated with decommissioning, new or modified systems as well as maintenance of the validated state of equipment, processes, and systems. Occasional opportunities for international and/or domestic travel may be available for this role.
The QA Engineer, Validation is responsible for helping to drive the Quality oversight for commissioning and qualification processes. This role is responsible for quality assurance oversight, review, and approval of validation activities and documents associated with new systems, changes to existing systems, maintaining the validated state of equipment/processes/systems, and decommissioning.
The Scientist 1, QC Analytical Development Chemistry supports the transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. This role ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. The Scientist 1, QC Analytical Development Chemistry authors transfer documents and executes testing as part of transfer for the following analytical methods: HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF)); general pharmaceutical properties methods.
The Analyst 1, QC Compendial Testing ensures laboratory operations are good manufacturing practices (GMP)-compliant according to United States\Europe\Japan pharmacopeia (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following TT activities, the position performs material testing and disposition using the established analytical methods.
The Scientist 1, QC Compendial Testing participates in the Technology Transfer (TT) of material methods into the FUJIFILM Biotechnologies, Holly Springs Quality Control Laboratory, with limited supervision. This includes the onboarding of new and generic raw materials as part of new customers/programs. This role provides assessments, identifies QC compendial testing requirements and executes action items as part of change controls for the onboarding of these materials based on vendor documentation. This position also identifies materials together with customers in a cross functional team as well as provides technical knowledge to assess testing approach, verification and validation needs both internally and at external contract labs. Following TT activities, the role performs release testing using the established analytical methods.
The Senior Analyst 1, QC Compendial Testing ensures laboratory operations are Good Manufacturing Practices (GMP)-compliant according to United States/Europe/Japan (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the Quality Control Laboratory as well as performs material testing and disposition using the established analytical methods.
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, AZ facility for a Talent Acquisition Specialist!
The Role
Taking direction from the Talent Acquisition Manager, the Talent Acquisition Specialist will have responsibility for sourcing, attracting, and identifying top talent and fill open requisitions for FUJIFILM Electronic Materials U.S. (FEUS) locations.
The ideal candidate has experience recruiting for chemical production, high-purity manufacturing, semiconductor materials, specialty chemicals, or pharmaceutical manufacturing. Success in this role requires a strong understanding of technical manufacturing positions, exceptional sourcing capabilities, and the ability to build trusted partnerships with hiring managers in a fast-paced production environment. This role is an onsite position. Remote or hybrid options are not available for this position.
FUJIFILM Cellular Dynamics, Inc. is seeking an expert in validation engineering who will apply knowledge of qualification and validation principles to manufacturing processes, quality systems, engineering design fundamentals, regulatory authority expectations and industry standards, as well as review and approve relevant documents. You will perform quality oversight of all validation for GMP including equipment, facility and utility systems, information technology, computerized systems, drug product manufacturing processes and methods.
FUJIFILM Cellular Dynamics, Inc. is seeking an Associate Director, Program Design to lead the scoping, design, and proposal development process for new CDMO business opportunities, from client request for proposal through contract signature. This individual contributor role serves as a key bridge between Commercial, Program Management, Site Leadership, Finance, Legal, R&D, Process and Analytical Development, Manufacturing, Supply Chain, Facilities, and Quality to translate client requirements into executable program scopes, assumptions, timelines, capacity plans, and pricing models. The role reports to the Director of Strategic and CDMO Marketing and is expected to bring strong technical, operational, and commercial judgment to support high-quality proposals, clear client communication, and efficient transition of awarded work into Program Management. Collaborates closely with the centralized Program Management group and serves as the local representative. This is an on-site position in Madison, Wisconsin.
The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). The role executes MSAT strategy, builds and develops a team of scientists and engineers, and optimizes large scale cell culture operations across seed/production bioreactors and purification trains. With a focus on innovation and reliability, this leader drives technical stewardship through tech transfer execution, process performance qualification (PPQ) execution, commercialization, as well as continuous improvement initiatives. This leader partners closely with the rest of the MSAT leadership team, Manufacturing, QA, Automation, and Engineering to improve systems and working methods. The Associate Director serves as the suite’s technical owner in client forums, translating product requirement needs into clear plans, stage gates, and flawless execution to enable compliant, on time Drug Substance delivery.
The Field Service Technician – Level 3 will report to the Regional Support Manager and will be responsible for the service and maintenance of either multiple product lines that the GCD service team supports or a high-speed inkjet product line. This level technician will demonstrate a full working knowledge of the product lines they support including theory of operation as well as the mechanics. This position will require travel throughout the United States.
This is a remote position within the Dallas, Texas area.
The Senior People and Culture Operations Partner serves as the main point of contact and resolution for all PNC queries, including Workday and policy advice in line with best practice, from employees, managers and leaders. This roles This position also assists with Business Partner activities to support an engaged workforce.
The MRO Specialist under the supervision of the Sr. Manager Facilities Support Operations is responsible for buying, deliver and replenish spare parts, using the Computerized Calibration & Maintenance Management System (CCMS/CMMS) in support of multiple manufacturing facilities such as the National Center for Therapeutic Manufacturing (NCTM), the Texas Biological Facility (TBF) and the Flexible Biological Facility (FBF) on behalf of Fujifilm Diosynth Biotechnology Texas (FDBT). Primary responsibilities include managing the daily spare parts operations such as screening of incoming work orders, identification of parts required, and procurement of parts, equipment and specialized tools. Scheduling of parts inventory control and monitoring of maintenance tasks performance. This position will interact with other maintenance and technical trades, such as manufacturing operators, engineers, calibrations and maintenance technicians, validation, quality and external suppliers in order to provide a high level of excellence over the maintenance support activities of FDBT.
The Maintenance Technician I, under the supervision of the Facilities Maintenance
Supervisor, or designated supervisor will be responsible for performing various aspects of utilities,
facilities and process equipment maintenance and support for the Texas Biological Facility (TBF),
the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing
(NCTM) on behalf of Fujifilm Biotechnology Texas (FlBT).
Primary responsibilities include various aspects of maintenance and support for facilities, utility
equipment and biotech processing equipment.
This position will be required to use technical manuals, on-line resources and OEM
representatives to maintain the equipment operational with a minimum of downtime. Strict
adherence to Standard Operating Procedures (SOPs), cGMPs and Quality Standards in a
Pharmaceutical Manufacturing facility are mandatory.
The Clinical Specialist (RDCS Certification Preferred) - Washington, DC, 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 Washington, DC metropolitan area as this would be a central location relative to the territory's business.
Job Purpose
Provide timely and accurate financial information and analysis to support the business with strategic and tactical decisions.
About Fujifilm
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 COUS business is currently embarking on strategic transformation period after a significant capital investment which will herald a shift in commercial opportunities to the site.
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