The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.

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.   

Summary:  The Quality Assurance (QA) Compliance Specialist III – Change Control, will be responsible for supporting performance of the Quality Systems group.  The Specialist will assist with the tracking and coordination and closure Change Control records.

Reports to                Manager/Sr. Manager, Quality Assurance  

Work Location         College Station, TX 

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.

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.