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.

The Clean Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies.

The Black Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Black Utilities, including Chilled Water Systems, Steam Boilers, Cooling Towers, HVAC and Glycol Chiller and Compressed Air systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability.

Readiness Engineer I is an entry to mid-level position in the Manufacturing department. This position will report directly to the US/DS Readiness Lead but may also have a functional reporting relationship with a senior colleague on a project-to-project basis.

This role works independently and with colleagues to provide expertise and assistance for the design, development, standardization, and maintenance of operational biotechnology utilized in the manufacture of proteins and drug substances. This person would be the liaison between the technical transfer team and Manufacturing and will provide input into the Processes being transferred to Manufacturing to ensure that the Process Designed is executable in Manufacturing. Additionally, this engineer may be assigned to revise records between runs or batch campaigns, prepare study plans and prepare and execute engineering test plans, as needed.

The Senior Engineer functions independently and productively within a team based organization to actively address complex cGMP manufacturing issues.  The individual is responsible for analyzing process technologies in support of new project proposals and takes responsibility for the technical transfer into the manufacturing group for Clinical and/or Commercial. This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a CMO environment. 

As the Manager, Data Enablement & Analytics, you will understand that data is the key to the future success of the company, and this role is essential to ensuring we have reliable data insights to inform business decisions at every level.  This position will be responsible for developing a strategy to ensure our processes and systems are set up to create the data insights the business is looking for.  The key to success in this role is creating a data environment that produces reliable insights in every area of the business. 

The Senior Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our manufacturing facilities at FDBT. Lead the Quality Operations organization to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Direct all QA on-the-floor (QAOTF), batch record review (BRR), and product disposition activities including QA review and approval of any associated deviations, CAPAs, and change controls to meet established targets for right first time execution and on-time delivery.  Ensure products are manufactured to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.

The Sr. Specialist 1, QC Technical Transfer and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 1, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

This will be up to a 3-month paid internship (hourly rate range $25-$30/hour, commensurate with experience) focused on characterizing, developing, and optimizing chemical processes. This is a temporary position employed by SwipeJobs, working on site at Fujifilm Dimatix.

• KNOWLEDGE: Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
• JOB COMPLEXITY: Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.
• SUPERVISION: Normally receives detailed instructions on all work.
• EXPERIENCE: Typically requires no previous professional experience

The Industrial Engineering Intern position will be up to a 3-month paid internship, hourly rate range $25-$30/hour, commensurate with experience. Industrial Engineering Intern will be assisting the Continuous Improvement team which may include any of the following activities: Measuring and analyzing work practices such as labor and machine times, identifying productivity improvement opportunities, layout validating and planning, designing training checklists and tests, updating procedural documents, auditing existing processes, participating in 5S activities, and analyzing capital equipment utilization.

• KNOWLEDGE: Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
• JOB COMPLEXITY: Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.
• SUPERVISION: Normally receives detailed instructions on all work.
• EXPERIENCE: Typically requires no previous professional experience

This is a temporary position employed by SwipeJobs, working on site at Fujifilm Dimatix. 

We seek a MEMS Development Engineering intern who is actively enrolled as a full-time student pursuing an Undergraduate or Graduate degree in Material Science, Chemistry, Chem-, Bio- or Nano-Engineering, or a related field, at a four-year university. This intern will work with a cross-functional team that interacts across different areas of device fabrication to develop next generation products. This will be up to a 3-month paid internship, hourly rate range $25-$35/hour, commensurate with experience.  This is a temporary position employed by SwipeJobs, working on site at Fujifilm Dimatix.

We seek a Failure Analysis Engineering intern who is actively enrolled as a full-time student pursuing an Undergraduate or Graduate degree in Material Science, Manufacturing Engineering, MEMS, Physics, Semiconductors, Mechanical Engineering, or a related field., at a four-year university. This intern will work with a cross functional team that interacts across different areas of wafer fabrication processing to improve yield and overall product performance.This is a temporary position employed by SwipeJobs, working on site at Fujifilm Dimatix. This will be up to a 3-month paid internship, hourly rate range $25-$35/hour, commensurate with experience.

The Senior Environmental, Health and Safety (EHS) Specialist supports and implements the company’s Safety, Environmental, and Health Programs to ensure compliance with local, state, and federal regulations, as well as corporate policies. This role fosters a culture of safety and environmental stewardship while driving proactive measures, continuous improvement, and supporting EHS initiatives in laboratory and biosafety settings.