The Director, Automation is responsible for setting the direction and managing a central workstream in a $2 billion global project. This includes developing and executing plans to enhance operational efficiency, streamline processes, and leverage technology for improved performance. As the Director, this role bridges the gap between technical expertise and business objectives to drive innovation, efficiency, and execution. Additionally, this role ensures that the right people are assigned to the right tasks and projects providing challenge and enhancement to their skills.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to...

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others.  This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.  

The Sr. Analyst 1, QC Virology works with limited direction to execute QC analytical methods requiring aseptic technique, including viral infectivity assays, mammalian cell culture, growth and purification of viral stocks, titering of viral stocks, and PCR-based methods. The Sr. Analyst 1, QC Virology adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The Sr. Analyst 1, QC Virology is primarily responsible for executing routine Virology methods in support of manufacturing, supporting laboratory execution of method qualifications, maintaining cell banks and...

The Technician 1, Maintenance is responsible for assisting installation, maintenance, and repair of process related systems/equipment. Ensure these systems meet the stringent requirements of pharmaceutical manufacturing. Also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime.

The CMMS Admin enters and maintains accurate data, such as equipment records in the Computerized Maintenance Management System (CMMS). This role generates basic reports and metrics to support maintenance operations. Additionally, this role supports IT with system troubleshooting, user testing, and upgrades.

The Planner 3, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role uses knowledge of maintenance processes and regulatory requirements to plan, schedule, and coordinate maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role seeks opportunities for continuous improvement, collaborates cross-functionally to ensure successful completion of maintenance activities, and provides guidance to junior planners and other teams.

The Supervisor, Manufacturing Support is responsible for leading the material, training and production scheduling teams within manufacturing support and their associated activities to ensure compliant and reliable production.

The Supervisor, Drug Product Form & Autoclave supports start up and operational activities for the site. This role leads a shift team and is responsible for the manufacturing process and facility which will eventually operate in a 24/7 model.

The Clean Utilities Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies.

The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.

The Associate 3, EHS is responsible for supporting the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. As a single point of contact, this position will represent EHS and collaborate with assigned functional operations areas to instill a world class culture of EHS. Additional responsibilities include support of EHS engagement programs (EHS observations, GEMBA), training, audits, inspections, investigations, and collaboration with EHS personnel across the organization.

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a DAY SHIFT (Approximately...

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a NIGHT SHIFT...

The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).

The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. 

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...

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...

The Engineer / Scientist 2 of Process Analytics provides technology transfer support and technical oversight during manufacturing operations as it relates to process analytics data management systems and trending purposes. This role supports senior team members in all aspects of process analytics, including but not limited to closing deviations, generating master batch records, and data system improvement initiatives.

The Internal Event Planner leads the planning and execution of site wide company events both small and large sizes. This role manages end to end planning and execution of events along with managing a wide range of internal- and potentially external relationships and stakeholders. This role as internal event planner is pivotal in creating an engaging environment for all employees. The role requires a people-focused, self-motivated, and collaborative professional