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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.
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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.
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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.
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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...
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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.
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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...
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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.
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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...
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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.
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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...
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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...
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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.
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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.
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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...
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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.
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Position Description
We are hiring a Equipment Maintenance Technician. The Equipment Maintenance Technician will perform general production, packaging, quality and research and...
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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...
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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.
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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...
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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, Arizona facility for a QC Chemist!
The Role
The QC Chemist serves as a Quality Control Specialist...