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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)
This position is intended to oversee all technical aspects of Synapse product implementation, from solution validation phases through product go-live. The Project Engineer (PE) must have well rounded knowledge in all areas of medical informatics - IT infrastructure design and deployment, medical imaging industry expertise, and clinical environment workflow. In addition to technical expertise, PE's are also critical in HCUS's overall goals of delivering industry leading customer satisfaction, requiring excellent communication and verbal skills within project teams and externally with customers.
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 Sales Enablement Specialist will support the Sales Enablement team in the development and execution of New Product Introductions (NPI),End-of-Life (EOL) related tasks customer communication initiatives that help build brand awareness and support demand generation efforts for FFSS. Working closely with cross-functional partners such as product management, market development, clinical and digital marketing, this role will assist in carrying out marketing communication plans, NPI and EOL project tasks, and multichannel campaigns designed to increase product awareness and generate leads.
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.
Position Description
We are hiring a Senior Regulatory Affairs Specialist. The Senior Regulator Affairs Specialist will be responsible for providing regulatory support and expertise including but not limited to the following product lines: Cell and Gene Therapy, Bioproduction, recombinant growth factors and Wako Lab Chemicals, Wako endotoxin testing reagents. Assist in the formulation disclosure review process in response to customer requests. Provide support in maintaining required licenses.
We are hiring a Document Control Labeling Specialist. The Document Control Labeling Specialist will compile and maintain control records relating to label issuance, print of production labels for manufacturing, assemble batch records (DHR) for all production departments and verify all documents including formulations, manufacturing protocols and Bill of Materials prior to lot folder assembly. They also will maintain label inventory, word processing of controlled documents and support the Document Control program.
Shift: 5am - 1:30pm
Position Description
We are hiring a Equipment Maintenance Technician. The Equipment Maintenance Technician will perform general production, packaging, quality and research and development (R&D) equipment repairs and maintenance to ensure the site meets cGMP and OSHA compliance. This employee is the on-site contact person for contractors and provides works including, but not limited to second shift, third shift on weekdays, weekends and holidays as assigned. They also respond to emergency production and packaging equipment troubleshooting needs.
This position will work 3rd shift 9pm-5:30am. The training will be on 1st shift for the first few months of employment.
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.
The Field Service Technician – Level 4 will be considered a specialist for a single product line that the TSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to all technicians. Will be considered the SME on the service team and lead other technicians with support and repair as required. This position will require travel throughout the United States.
This is a remote position within the Western region of the US between Texas and California - close to a major airport.
JOB PURPOSE
The objective of this position is to create and maintain the production plan for all product groups. To optimise and manage the supply of materials to meet the production schedule, balancing inventory across the supply chain network in line with customer service targets, demand and inventory targets to ensure operational continuity.
ABOUT FUJIFILM
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.
About FUJIFILM Locally: FUJIFILM Imaging Colorants, Inc. is part of FUJIFILM’s Ink Solutions Group comprised of 4 companies based in the UK and USA responding to the Group CEO and COO responsible for 3 of the businesses including FFIC Inc. FFIC Inc. has a manufacturing site in New Castle, DE where aqueous dyes, RxD, and inks are made to support the InkJet digital
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