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 /...

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.

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 Automation Engineer 3 will provide 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 focuses on leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection.

Summary:  

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...

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 Serviceswill 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...

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...

The Manufacturing Technician II work directly with a range of technologies. 

As part of our Global Finance team, you’ll partner with senior leaders, playing a critical role in our growth journey. You will have a comprehensive understanding of all the services offerings of our...

The Lead Associate 1, 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 training 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.

The Sr. Specialist 2, Global QC Raw Materials GMP Support is responsible for supporting, leading, and participating in activities within the Quality Control Raw Materials department as it relates to Investigations, Deviations, CAPAs and Change Controls. This role supports continuous improvements initiatives, customer contacts, and CLO communications to ensure Global QC Raw Materials (RM) capability of onboarding new materials, updating existing materials, implementing methods and ensuring campaign readiness as applicable.

The Sr. Specialist 2, Global QC Raw Materials (Documentation) is responsible for, but not limited to, implementing new raw materials, including specification authoring, requesting LIMS builds, and assessing changes. This role participates in planning and tracking QC readiness for clinical and commercial manufacturing, and ensures all documentation is in accordance with Good Manufacturing Practices (GMP) and that all reported results are accurate. The Sr. Specialist 2, Global QC Raw Materials onboards new materials in line with Fujifilm Diosynth Biotechnologies (FDB) and customer expectations. This role authors events, deviations, and CAPAs related to new materials, specifications, and other tech transfer activities.

Represents Service and Technical Support for a variety of cross-functional initiatives including NPIs, reliability improvements, and product return investigations. Serviceability expert for the Sonosite product line, lending knowledge and expertise throughout the company. Provides product training to service personnel, including external biomeds. Responsible for additional duties and projects, as assigned by manager, which require a high-level understanding of products and/or processes.

  **This is a hybrid role and will require being located in the greater Seattle area to be considered.**