The Quality Assurance Operations Engineer DSM (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 QA Engineer, Quality Control (QC) Materials Support oversees Quality Assurance during the operational phase. This role and the associated responsibilities develop as the project matures, and startup activities evolve. This role ensures systems and processes in the QC Laboratory are consistently operated and maintained in a validated state throughout their lifecycle. Emphasis is placed on policy administration and providing QA oversight for day-to-day activities, along with addressing and mitigating issues that arise during laboratory operations.

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 Supervisor, Quality Assurance Operations is responsible for providing supervision and risk-based QA support for the Drug Substance Manufacturing areas and processes.

The Investigator 2 is responsible to perform major investigations, identify root and contributing causes, contributes to the creation of effective corrective and preventative actions (CAPA) while ensuring timely closure of assigned investigations. This role also supports senior investigators with complex investigations as needed and provides guidance to junior investigators.

We are hiring a Liquid Packaging Technician. The Liquid Packaging Technician is responsible for Inspecting and labeling application for all filled product, case packaging of all sterile filled products into appropriate boxes, and bottle/vial preparation and staging.   1st Shift (5:00AM - 1:30PM)

The Sr. Analyst 1, QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell-based 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). This role supports the transfer and validation of methods such as residuals (HCP, DNA, Protein A), dot blot for product identity, ELISA ID/ Potency and various cell-based assays. The Sr. Analyst 1, QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and...

The Supply Chain Planner 3 role supports the project phase and operations of GMP Purchasing and Supply Chain Planning at FDBN to ensure that the right materials are available at the right time, in the correct quantity to support process validations and GMP production. This role supports the materials planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. This role is

The Supply Chain Compliance Specialist 2 is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support includes initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of

The Upstream Engineer/Scientist 3 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

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

We are hiring a Sr. Manager, Regulatory Affairs. The Sr. Manager, Regulatory Affairs will be responsible for ensuring that product, process, and procedures are sufficiently controlled to assure the quality of products and compliance in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, IVD D 98/79/EC, IVDR 2017/746, and Canadian Medical Device Regulation. Such and activities include writing, managing and leading preparation, creation and revisions of: Technical Files, Risk Management, Clinical Program, FMEA, Essential Requirements/ GSPR, outside reference standards and various regulatory external and internal support as required. The Sr. Manager, Regulatory Affairs oversees and manages...

The Environmental Health & Safety Manager will lead safety and environmental programs located in Richmond, VA and support multiple facilities, driving improved safety and environmental  performance through thorough and accurate incident reviews, implementing programs to increase safety awareness and compliance, and ensuring safety meetings and training are meaningful and engaging.   Provide oversight to ensure proper operation of environmental control system.

We are hiring a Calibration Engineer / Metrologist. The Calibration Engineer / Metrologist will be responsible for making sure FUJIFILM Irvine Scientific equipment, instruments, and testing devices are calibrated correctly and give accurate readings in line with Vendors’ standards. This employee will be expected to perform this role meticulously, as improper calibration can cause issues concerning safety, wastage, and faulty quality of products. Therefore, being able to provide the guidelines and strategical calibration approaches and attention to detail is vital, as well as problem-solving skills and the ability to work well and effectively with others.

  Position Summary:    The Procurement Internship will support the Procurement, Production Control, and Materials teams during summer 2025 to give the intern an understanding of Supply Chain Management:  

The Senior Electrical Engineer/Technical Project Manager (TPM) is a critical project leadership position within the Hardware Engineering department. You will lead the design and development of hardware products (e.g., computer hardware, peripherals, devices, and other electronic equipment) primarily within the electrical engineering...

The Intern (Supply Chain) supports the Warehouse, Raw Material Sampling, and Weigh & Dispense operations tasked with ensuring select processes are accurately modeled and documented for future operational efficiency. As part of the Supply Chain team, the Intern gains firsthand experience with supporting incoming materials, distributing to manufacturing, and collaborating between Warehouse and Manufacturing teams.   Start Date: This internship is set to begin...

The Intern (Quality Assurance (QA)) is part of the Inspection Readiness team tasked with tracking and delivering a sustainable Inspection Readiness Program in alignment with Good Manufacturing Practice (GMP) guidelines. As part of the QA team, the Intern gains firsthand experience with the regulatory requirements of GMP readiness and operations for a biological manufacturing site, tracks cross-departmental timelines and deliverables, and presents 

Who We Are   FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Pueblo, CO facility for an Inventory Control Specialist!   The Role  

The Facilities Maintenance Technician (temporary, 2 - 3 months) is responsible for the general housekeeping, upkeep, and maintenance of all building equipment and facilities.  The Facilities Maintenance Technician performs preventive and general maintenance and minor repair work on commercial buildings. The successful candidate will be highly organized, able to multi-task, and have...