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 Assistant Scientist – Upstream Process Development is an entry level position for graduates with no prior experience or training. The individual will learn and assist in the development and characterization of the upstream process of customer programs, and technology transfer to the manufacturing group as appropriate. This individual will be expected to require training on laboratory instrumentation and then use instrumentation to perform elementary lab experiments and document results appropriately.

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.

We have an exciting opportunity at our Mesa, AZ facility for an SCCM Administrator!  The System Center Configuration Manager (SCCM) administrator manages the deployment, maintenance, and updates of software, applications, and machine images across FFEM's networks. The SCCM Admin utilizes Microsoft software program SCCM to monitor, update, and secure large groups of computers across multiple domains.

Position Summary:  The Equipment Maintenance Technician opportunity is at Fujifilm Dimatix, Inc. in Lebanon, N.H.  The Equipment Maintenance Technician III is responsible for the maintenance of manufacturing equipment for production lines. Also responsible for troubleshooting and repairing downed equipment and may assist engineering staff in establishing and implementing periodic equipment maintenance. Technician may participate in safety forums, Emergency Response Teams and station improvement teams.

This position is intended to sell Ultrasound imaging systems, options, and service contracts to prospective and existing customers in their assigned territory.

The Automation Engineer 3, DSM Downstream 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.

The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.   

Utility Maintenance 2 will perform corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs). Complete work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. Utilities to include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and you and your team will work a 2-2-3, 12 hour shift schedule to support the ongoing activities in Downstream Manufacturing.

This position is intended to sell Fujifilm medical imaging devices, options, and service contracts to prospective and existing customers in their assigned territory, Arizon / Utah and Las Vegas locations. 

The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

The QC Analytical Development (AD) Chemistry Scientist 2 is responsible for coordinating the transfer of analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The QC AD Chemistry Scientist 2 ensures GMP compliant laboratory operations in accordance with regulatory guidelines. This role coordinates analytical method transfers from clients, including the following analytical methods: chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.

The QC AD Chemistry Sr. Analyst I works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The QC AD Chemistry Sr. Analyst I adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and authors and reviews procedures, SOPs, and technical reports. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

The Analytical Development (AD) Tech Transfer (TT) Scientist 2 manages and coordinates the transfer of drug substance and drug product QC analytical methods from customers into the large-scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and cross-functional teams to scope analytical testing plans and achieve project milestones. This role authors/reviews transfer plans, method transfer documents, transfer summary reports and specification justification reports, as needed. This role effectively communicates and operates between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology.

The Technician 2, Maintenance is responsible for the installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime.

QVS Engineering is a growing team whose mission is to improve the quality of FFSS products through their life-cycle, proactively handling component and module obsolescence while strategically reducing COGS (Cost of Goods Sold). The Senior Electrical Engineer (QVS) works with a cross-functional team to resolve complex ultrasound systems’ quality issues, defining and implementing innovative modifications to existing electrical designs to reduce cost while still maintaining high quality, and handling obsolescence of electrical/electronic components. Specific requirements include electronic troubleshooting experience using advanced lab equipment on circuit boards with large BGAs, expertise in power supplies/power converters, low power design, electronic component selection, and grounding schemes. Experiences in analyzing high speed signals, knowledge of standard buses including PCI express, USB and I2C, knowledge of memory technology, ASIC and FPGA are also required. Experiences with circuits that meet stringent EMI and RFI requirements are highly desired. Previous experience working with FDA-regulated products is highly desired.

The Tech 2, Instrumentation & Controls (I&C) is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Preventive and Corrective Maintenance and Calibration practices and know-how.

As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment.  This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools. 

This position requires previous capital medical equipment sales experience.

To best serve the territory, prefer candidates currently located in the Cleveland area

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.