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The CAD Specialist, guided by the Principal Engineering Manager–Engineering Projects, is tasked with enhancing the CAD function and defining the engineering document management strategy at the College Station site. Responsibilities include routine to moderately complex design and drafting for engineering, manufacturing, facilities, and validation. The role involves maintaining FDBT's engineering documents—including drawings, blueprints, P&IDs, and technical manuals—in both hard copy and electronic formats.
Duties also encompass verifying and updating equipment and facilities documents in collaboration with contractors, engineers, and validation staff, managing changes through authorized engineering change control....
This position is intended to sell Ultrasound imaging systems, options, and service contracts to prospective and existing customers in their assigned territory.
This position is intended to process all outgoing shipments, incoming purchase orders, incoming returned goods, schedule, and process parts for repair, maintain the order and the neatness of the warehouse, assist in the physical counts of inventory, respond to off-hours emergency parts requests, and perform all other duties as assigned.
The Production Technician 4 leads and executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.
GENERAL PURPOSE
The primary purpose of this position is to manufacture RxD dispersions at the COUS site.
The Production Operator must be responsible to perform all manufacturing activities within all EHS, quality, and corporate guidelines on a right-first-time basis. The operator is independently responsible for manufacturing activities and priorities, following all appropriate training programs, complying with all documentation...
About This Role
The QC Sr. Specialist 1, Instrumentation works independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role ensures the performance of routine maintenance, completing periodic reviews of QC analytical instrumentation to confirm compliance and correct...
The Director, Engineering Science plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) of the organization. This role assesses and designs processes to integrate new equipment, optimize facilities, and enhance operational capabilities. The Director, Engineering Science leads engineering studies, drives improvements in Drug Substance Manufacturing (DSM), Drug Product and Finished Goods (DPFG), and ensures innovative solutions are implemented effectively. This role is crucial in enhancing site’s process equipment and technology capability offerings and maintaining competitiveness, by making significant...
The Principal Engineering Manager – Reliability Engineering at Fujifilm Biotechnologies Texas (FLBT) plays a crucial role under the guidance of the Director of Engineering. This position is being established to provide the maintenance and reliability strategy for the department with direct accountability for ensuring equipment/process uptime through management of key metrics (MTTR, MTBF, OBE, OEE) and continuous improvement. In addition, support will be required for maintenance and optimization of the process and equipment across drug substance, drug product and general operational areas. The role combines both a hands-on approach along with leadership skills to perform...
As the Senior Director, Process Engineering & Maintenance, this role is responsible for setting the direction and managing central workstreams in the start-up of a $2 billion project. This role leads the process engineering and process maintenance organizations to ensure the successful start-up and ramp-up to meet client commitments ensuring the equipment maintains a state of readiness. Additionally, this role is responsible for designing and implementing manufacturing processes, equipment, and technology while building the team and ensuring flawless execution by leveraging existing experience as a subject matter expert (SME) and people management capabilities in start-up...
The Endoscopy Demo Coordinator Specialist is the logistical focal point of accountability for all medical device demo distribution and status. This role is pivotal in ensuring the highest levels of customer satisfaction to our direct sales representatives and partners by meeting demo needs.
The Inbound Inspector is responsible for the inbound inspection for all endoscopes returned to the facility for service and/or repair. Performs initial inspection, defines the necessary repairs and lists the parts and components needed to complete the repair process. Works on all models of Loaner/Demo and Customer scopes.
The Manager of Compliance & Support, DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps, authoring departmental standard operating procedures (SOPs), creating master batch records in electronic systems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training coordinators. The role also supports...
This entry-level 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.
The HL7 Integration Engineer (IE) for Canadian region oversees all technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical imaging industry in general and clinical environment workflow. In addition to technical expertise, HCUS relies on HL7 IE to deliver industry leading customer satisfaction, requiring excellent communication and verbal skills within project teams and externally with customers.
The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.
The QA Engineer, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Engineer, DSM ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
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 a Controller!
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...
At Fujifilm Sonosite, we are looking for an experienced Sr. Compliance Engineer who will be responsible for providing global product compliance analysis and guidance to ensure that all electrical, mechanical and other regulated performance specifications are satisfied in all countries where Fujifilm Sonosite’s business exists or will expand. You will be part of a Regulatory Compliance team that conducts global due diligence for product compliance requirements, monitors emerging regulations and new standards, develops compliance specifications and policies, builds compliance programs to support Fujifilm Sonosite’s business initiatives, and troubleshoots...
As an FPGA Engineer III, you will be responsible for implementing innovative FPGA solutions that enable Fujifilm Sonosite ultrasound systems to meet real world clinical needs. You will work with a diverse group of talented engineers from Electrical, Systems, Ultrasound, and Software teams to design the next generation of ultrasound systems using the latest FPGA technologies, FPGA design processes, and tools, from product conception all the way to production. You will have the opportunity to lead projects where you will need to interact with external experts and vendors to understand, integrate and implement new enabling technologies. To be successful in this...
As a Senior Electrical Engineer, you will be responsible for the development of clinical ultrasound systems. This role will provide project leadership and electrical design through all development stages, including requirements definition, architectural design, circuit design, layout, bring-up, system integration, test, debug and verification. You will be a subject matter expert (SME) with strong working knowledge of analog, digital, signal processing and low-noise subsystem design. This role requires familiarity with all aspects of the system level design including the analog front-end, A/D acquisition, digital signal processing and imaging functions....