This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Aura project, a greenfield construction project in Holly Springs, NC.  The initial assignment is to assume the Responsible Engineer role for Chromatography and Column Packing unit operations.   

The Manufacturing Equipment Engineer will drive continuous improvement of Dry Etch equipment working with process engineers. Work with maintenance team on training effectiveness, spare parts management and design weaknesses. Act as lead for new tool installs and qualification, securing necessary internal and external resources to drive projects to completion. Using expert tool knowledge, selects, installs, modifies, upgrades and maintains equipment most appropriate and cost effective for manufacturing operations. Establishes programs and solutions for increasing up-time and for equipment problems that affect the manufacturing process. Define calibration process for bench top...

The Head of Global Program Management (VP) is responsible for leading the Global Program Management team in the Manufacturing Sciences organization to ensure timely manufacturing campaign starts of robust operations and is a member of the global Operations Leadership Team.  Other projects may be managed as well, for example new technology implementations or special studies carried out within the manufacturing environment.  Deployment of standard work processes and developing the global culture to embrace them is critical to success, and measured by low stress, highly efficient project teamwork.  Active participation in global planning, and the development of...

The Quality Control Chemist I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.

The Quality Technician performs functions associated with quality control and quality assurance operations, including working with engineers in set-up and calibration tasks and carrying out rework and quality assurance procedures related to production or operations. Uses sophisticated programs to collect and evaluate data to assist in assessing and documenting results of quality assurance and control processes. Determines and may assist in developing methods and procedures for quality assurance and control. Works with engineers in conducting experiments, and to ensure the documented manufacturing procedures are implemented, maintained and well monitored. To achieve that goal,...

We have an exciting opportunity at our North Kingstown, RI facility for a Senior Process Engineer!  The Senior Process Engineer will lead manufacturing engineering activities for batch-process-based product lines. This role involves full ownership of a product line while contributing to the success of additional lines. The Senior Engineer will oversee all aspects of the product lifecycle, ensuring quality standards for materials are maintained and committed ship dates for finished products are met. Responsibilities include evaluating supplier changes, developing qualification plans for validation, and implementing continuous improvement projects. The...

The Sr. Specialist, Regulatory Affairs, provides critical insights on FDA and EMA expectations while planning and executing expansion meetings with regulatory authorities. This role serves as a liaison between commercial, operations, and expansion project teams, guiding efforts to maintain manufacturing flexibility with minimal regulatory impact. Sr. Specialist establishes and maintains the site master file, licenses, and eCTD documentation, as well as participates in a cross-site regulatory network and sustainability initiatives.  Additionally, this role acts as the primary...

We have an exciting opportunity at our Hollister, CA facility for a Quality Control Engineer II!  The Quality Control Engineer II will work to ensure all metrology equipment provides a high level of quality that meets internal and external customer’s expectation. This individual will put in place a system to measure each critical metrology equipment performance, drive continuous improvements, and then report on its status with QC Chemists, Process Engineers, management, and key customers to address any deficiencies.

The Manufacturing Supervisor works as part of the Manufacturing team to deliver on goals to generate high quality materials that can be used both in the clinic as well as commercial.  This position will contribute to the successful delivery of released product in support of clinical trials and commercial requirements.  The Manufacturing Supervisor will work in different activities including manufacturing processes, facility cleaning, document review, inventory control and materials management.  The position will also provide manufacturing processing input for the design and operation of computer systems (MES, ERP, LIMS, QMS, EMS).  The candidate will also understand the...

We are hiring a Clinical Affairs Specialist. The Clinical Affairs Specialist will be responsible for assisting in the development and generation of Clinical Evaluation Plans and Reports (CEPs, CERs), conducting clinical literature searches, performing analysis of clinical literature, and evaluating and reviewing clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Specialist will assist in performing annual...

The Microbiology IV will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  This position is a pivotal role to either a technical career path as a Microbiologist IV or a managerial career path as a Lead for the team, and a successful individual in this role will lead the team regardless of the career path they decide to pursue.  

The Quality Control Chemist II, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  Following Tech-Transfer Activities, the candidate will be responsible for performing release and stability testing using the established analytical methods.   Reports...

The Manager, QC Virology oversees the QC Virology team, ensuring GMP-compliant laboratory operations in accordance with regulatory guidelines. This role involves direct management of PCR, RT-PCR, qPCR assays, Adventitious Virus (AVA) testing, and Mouse Minute Virus (MMV) testing. As a technical subject matter expert, the Manager provides support for troubleshooting complex investigations and optimizing laboratory systems while ensuring accurate documentation and compliance with GMP standards. Additionally, this role represents the QC Virology team during customer and regulatory audits and foster the development of team members through effective leadership.

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.  

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

We have an exciting opportunity for an SAP MII Developer!  The MII Developer will be responsible for managing projects and production support activities. Our ideal candidate should have 3+ years of experience with SAP MII Implementation / Designing Solutions / Development. The candidate must understand the internal working on SAP MII including but not limited to BLS, QT, Event Processing, and Alerting. Strong understanding of SAP NetWeaver is a must.

We have an exciting opportunity at our Mesa, Arizona facility for a Senior Research Chemist in our CMP group!  The Sr. Research Chemist will support new Chemical Mechanical Polishing/Planarization (CMP) slurry formulation development and provide chemistry/chemical component expert consultation to the technology development team. The primary focus will be formulation development for BEOL/MOL slurries for next generation semiconductor technologies.

We are hiring a Sr Manager, HRBP who will work a hybrid schedule out of our Valhalla, NY office.  Responsible for the management and delivery of core people and capability programs, including talent and performance management, year-end compensation planning and workforce planning within a business line.   Responsible for oversight of a facility and/or managing 1+ HR staff member(s).

We have an exciting opportunity at our Mesa, AZ facility for a Cyber Security Analyst!  The successful candidate will be responsible for assisting with the day-to-day operations of securing our various information systems. Reporting to the IT Infra/Security Manager, the CSA is tasked with providing technical expertise in all areas of network, system, and application security.

We have an exciting opportunity at our Mesa, AZ facility for an Applications Manager!  The successful candidate will be a vital leader in assisting businesses to achieve success, with responsibility for researching and acquiring the software applications required to propel growth forward. They will configure, monitor, and maintain these tools as needed, ensuring that they are used across departments. Furthermore, they are responsible for managing financial budgets associated with both projects and day-to-day operations, all while supervising server/hardware upgrades and reporting success to top management and stakeholders.