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The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Diosynth Biotechnologies, Holly Springs (FDBN) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBN Quality. The Sr. Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.
This position is intended to sell Ultrasound imaging systems, options, and service contracts to prospective and existing customers in their assigned territory.
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 Purchasing Manager!
The Role
The Purchasing Manager will manage raw material commodity strategies and hold suppliers accountable for top performance in Chemicals, Packaging and MRO. This role is responsible for securing best overall value while continuing to ensure that purchased materials support quality, cost, delivery, and service levels. This position works closely with Finance, Quality, Manufacturing, Engineering, R&D and Facilities, provides leadership in problem solving, price negotiations, cost containment strategies and enhancing supplier relationships.
The Manufacturing Specialist 2, MES & DCS performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to DeltaV Distributed Control Systems (DCS) and Manufacturing Execution System (MES). The manufacturing facility will be 24/7 operational and the role may require flexibility with working hours and shift rotation.
The Manufacturing Specialist 2, SAP performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to Systems, Applications, and Products in Data Processing (SAP) material transactions. This manufacturing facility will be 24/7 operational and the role may require flexibility with working days and/or nights and shift rotation.
The Account Executive, ES (Territory - New Hamphire, Vermont, Maine) is responsible for the generation of sales revenue for the organization through personal interaction with prospective customers within a given territory. This position is expected to promote the use of core products within prospective customer accounts, maintain current customer accounts to ensure a solid reference base and educate the general market on the benefits of the product. This position must establish a solid network of reference with “partner” representatives who supply the same customers with non-competitive products and maintain a thorough understanding of competitive products and competitive positioning to ensure success and become a true “Endoscopic Consultant” for the customer. Has overall responsibility in achieving a 10% annual increase of market share.
The Manager, QC Laboratory Information Management System (LIMS) is responsible for developing strategic plans for implementing FDB's global Laboratory Information Management System (LIMS). This role harmonizes processes across all current and future FDB sites and leads the transition of QC into a paperless environment. The Manager, QC LIMS guides a team of LIMS experts to translate global and site-specific needs into user requirements, system design, configuration, and implementation plans. This role acts as the primary subject matter expert (SME) for LIMS and focuses on maintaining and continuously enhancing the global LIMS system.
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 North Kingstown, RI facility for an R&D Chemist!
With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products and services used throughout the semiconductor manufacturing process.
The Role
The successful candidate will work with the larger Photopolymers R&D team to develop new photoimageable dielectric materials and photoresist formulations. This role involves collaboration with central R&D and product technology teams to drive raw material selection and formulation improvements.
The ideal candidate will have experience in both organic synthesis and material formulation/testing. Additionally, the R&D Chemist will apply experimental design, problem-solving skills, and root cause analysis to innovate and enhance product performance, while providing support in troubleshooting material-related issues.
We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams.
These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational. We will have a day shift and a night shift. We are hiring for night-specific roles; however, all roles may require flexibility with working hours and/or shift.
We operate on a 2-2-3, 12 hour shift schedule (days or nights).
*** Please note that this posting represents multiple openings ***
Director, QA Drug Substance Operations
Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations.
In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams.
As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment.
The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation.
The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization to drive continuous improvements within the team. As member of the site Quality leadership team contribute to cohesive execution of quality initiatives and projects throughout the site in Holly Springs.
This position is responsible for technical repair and final quality inspection on assigned Endoscopic units. This position is responsible for consistently meeting monthly repair targets while adhering to all safety policies and procedures.
Manufacturing Associate (1st Shift, Transducers) - Bothell, WA
This position is responsible for performing a variety of tasks associated with manufacturing diagnostic ultrasound transducers. Specific tasks may include some of the following:
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 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.
The preferred location for this position is Maryland, USA.
The Automation Engineer 3, DSM Upstream 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 supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.
This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.
This role performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.
We have an exciting opportunity at our Mesa, AZ facility for a VMWare-Veeam Administrator!
The VMware system administrator manages FFEM’s VMware environment, including storage and network management. They design, configure, and support virtual systems. They also maintain, upgrade, and improve virtual hardware, resources, systems, and key processes.
They will manage all aspects of Veeam Backup & Replication, including creating and managing backups, recovering data, and configuring settings.
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