The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 

The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.

The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization to drive continuous improvements within the team. As member of the site Quality leadership team contribute to cohesive execution of quality initiatives and projects throughout the site in Holly Springs.

The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the GSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.

This is a remote position.  The ideal candidate is located in, or willing to relocate to, the Pittsburg, PA area.  

The Graphic Communication Division of FUJIFILM North America Corporation is the largest graphic distributor in the US. We deliver world class, state of the art solutions for Ink Jet Printing, Digital Printing, Wide Format, Offset Plates, Packaging, and a full range of traditional Offset supplies. In addition, we are the industry leader in Color Standardization and G7 implementation. 

The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the GSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.

This is a remote position.  The ideal candidate is located in, or willing to relocate to, the Akron, OH area.  

The Graphic Communication Division of FUJIFILM North America Corporation is the largest graphic distributor in the US. We deliver world class, state of the art solutions for Ink Jet Printing, Digital Printing, Wide Format, Offset Plates, Packaging, and a full range of traditional Offset supplies. In addition, we are the industry leader in Color Standardization and G7 implementation. 

The Field Service Technician – Toner Production Equipment will be considered a specialist for a product line that the GSD service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. Will provide solutions to complex problems as well as provide field and/or remote support to technicians.

This is a remote position.  The ideal candidate is located in, or willing to relocate to, the Cleveland, OH area.  

This 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.

Manufacturing Associate (1st Shift, Transducers) - Bothell, WA

This position is responsible for performing a variety of tasks associated with manufacturing diagnostic ultrasound transducers.  Specific tasks may include some of the following:

The Field Service Technician – Level 3 will report to the Regional Support Manager and will be responsible for the service and maintenance of either multiple product lines that the service team supports or a high-speed inkjet product line. This level technician will demonstrate a full working knowledge of the product lines they support including theory of operation as well as the mechanics. This position will require travel throughout the United States.

The preferred location for this position is Maryland, USA.

The Automation Engineer 3, DSM Upstream 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. This role focuses on supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest. 

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

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.   

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 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.