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

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 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.

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.

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.

We have an exciting opportunity at our Mesa, Arizona facility for a Material Handler Technician!  The role of the Material Handler Technician is to support CMP Manufacturing with the necessary raw materials/supplies to sustain HVM operations without interruption.

As the Manager, Data & 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.

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.

The Supervisor Quality Assurance Compliance – External Audit will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. The teams are broken up into two core functional groups: One will be overseeing the successful delivery of internal audits and the other one will be overseeing the successful delivery of external audits. You will be assigned to supervise one group or the other but may be asked to provide support to the whole Audit & Inspection group on occasion.

The Western Zone Pulmonary Sales Specialist is a key member of the Fujifilm Endoscopy sales team that is responsible for driving awareness, market share, and revenue growth across Fujifilm's Pulmonary product line. This includes flexible scopes, Endobronchial Ultrasound (EBUS), and all other pulmonary franchise offerings. The role is accountable for business development, strategic partnerships with Key Opinion Leaders (KOLs), and collaboration with the existing Fujifilm Endoscopy sales and clinical specialist teams to ensure successful demonstrations and customer satisfaction. Reporting directly to the Regional Sales Leader, the Zone Pulmonary Sales Specialist plays a pivotal role in expanding Fujifilm's presence in the pulmonary space.

To best serve the territory, prefer candidates currently located in the Western US region.

The Raw Materials QC Manager is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for direct management and supervision of the QC Raw Materials teams performing raw material testing according to USP/EP/JP guideline and releasing raw materials for use in the drug substance and drug product manufacturing process. The Manager, QC Raw Materials is responsible for managing raw material specifications, handling changes from customers on customer owned materials as well as handling and implementing new raw materials and consumables as part of tech transfer activities. In addition, the QC Raw Materials team is responsible for testing, disposition, and release of raw materials and Trackwise support or investigation of deviations including Out of Specification (OOS) results. Provide managerial support for troubleshooting of complex investigations and optimizing laboratory systems. Ensure that the laboratory is maintained in a state of GMP compliance. All documentation is in accordance with GMP and all reported results are accurate. The Manager, QC Raw Materials is the technical subject matter expert (SME) and participates in assessing the testing of raw materials and excipients, represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids in the development of QC team members.

The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.  Responsibilities will include one or more PQS sub-system: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.  Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Ensure the site PQS sub-system is aligned with the harmonized global FDB PQS, organizational goals and objectives, and areas of continuous improvement.

This position is intended to provide mechanical and technical installation and repair for new/existing super-conductive MRI systems at customer sites.

The Automation Engineer 2, DSM - CSV will provide support to the Drug Substance Manufacturing (DSM) facility. This includes preparing validation  documentation, contributing to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems, and being a part of Automation on-call support as needed. This role will partner with other departments locally and other sites to align strategies and procedures. This role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. Additionally, there will be involvement in facilitating improvement initiatives and supporting regulatory agency and third-party inspections.

The Associate Manufacturing Supervisor is responsible for coordinating manufacturing operations to meet and exceed quality, cost and delivery commitments. Position is a “working” position, in which the individual will supervise the activities of others while assisting in the day-to-day operations.

This position will have supervisory responsibility over a shift of Manufacturing Technicians in a Wafer Fab responsible for the manufacture of MEMS-based products.  Ideal candidates will have demonstrated experience supporting the development of manufacturing excellence across a multi-shift production operation.

Pay range for position: $35 - 45 per hour, commensurate with experience.

Compressed Work Week-Back End Nights - Every Thursday, Friday, Saturday and every other Wednesday.  5:30 pm- 6:00 am

Manufacturing Technician - 2nd shift

We're excited to offer a MANUFACTURING TECHNICIAN opportunity at our North Kingstown, RI facility, where we manufacture high-purity chemicals and solvents as part of the semiconductor industry supply chain. In this role, you'll support our 2nd shift operations, ensuring products are processed and packaged safety and efficiently to meet production goals. You'll gain hands-on experience with state-of-the-art equipment and contribute to the overall manufacturing process.

Whether you're starting your career or looking to grow in manufacturing, this position offers the chance to learn and make a real impact in a dynamic, fast-paced environment that supports cutting-edge technology.