The Supervisor, Maintenance is responsible for overseeing and coordinating the operations of maintenance systems and the team of process maintenance technicians within assigned area to support Drug Product (DP) or Drug Substance Manufacturing (DSM) to ensure smooth and efficient operations. This role focuses on maintaining and managing equipment, vendors, and daily operational activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practices (GMP) standards. Additionally, this role provides training, technical support, and leadership to the process maintenance team.   Multiple openings across day and night shifts

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

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.   we have multi positions open- days and nights shift

Utility Operator 2 operates, maintains, and repairs black and clean utility systems. This position is also responsible for monitoring mechanical and electrical equipment, power distribution, chilled water, process gas, domestic and de-ionized water, water for injection (WFI), clean steam generator and distribution, plant steam boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. Additionally, this role performs daily monitoring of tank farm, supports lab admin building, building management system (BMS) and critical alarm response. 

Utility Operator 2 operates, maintains, and repairs black and clean utility systems. This position is also responsible for monitoring mechanical and electrical equipment, power distribution, chilled water, process gas, domestic and de-ionized water, water for injection (WFI), clean steam generator and distribution, plant steam boilers, compressed air, fire alarm, security, remote building equipment monitoring, sanitary, acid waste, and storm drain systems. Additionally, this role performs daily monitoring of tank farm, supports lab admin building, building management system (BMS) and critical alarm response.   

The Tech 3, 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.    

The Supervisor of Utility Operations is responsible for overseeing and coordinating the operations of utility systems and the team of utility operators to ensure smooth and efficient operations. This role focuses on maintaining and managing equipment, vendors, and daily operational activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practices (GMP) standards. Additionally, this role also provides training, technical support, and leadership to the utility operations team.   

The Technician 3, Maintenance is responsible for the 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.   we are hiring for multiple positions across day and night sifts      

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 Manufacturing Support Associate 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.

The Building Information Modeling (BIM) Services Administrator plays a crucial role in managing and optimizing the use of Computer Aided Design (CAD) and BIM technologies. This position is responsible for maintaining and managing central models, facilitating collaboration among stakeholders, and ensuring that all CAD and BIM processes align with organizational standards. This role works closely with project teams to streamline workflows, enhance data integrity, and support the successful execution of projects. Additionally, this role utilizes a proactive approach to problem-solving in a fast-paced environment while leveraging strong technical knowledge in CAD and BIM technologies from prior experiences.

The Supervisor, Drug Product Filling 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 24/7 model.

The Senior IT Engineer 1(OSS Platform) is responsible for operations and maintenance of the local Open Source technology stack to support manufacturing operations from an IT/OT perspective in a global organization. This position acts as a single point of contact and escalation for the locally used systems and ensures the most appropriate level of service is supplied to meet future business needs. This role will initially be part of the local IT project team responsible for implementing all infrastructure and applications necessary to bring FDB’s new site in Holly Springs, NC, online. This role functions as a local extension of the Global IT team reporting into the Sr. Director - IT....

The Warehouse Associate 2 position is responsible for storage, handling, and distribution of materials and products. This role supports Warehouse operations in receiving, shipping, and/or logistics throughout FDBN and works with multiple functions to support operations (e.g., Manufacturing, Quality, Process Sciences), The Warehouse Associate 2 uses Systems Applications and Products (SAP) ERP system for inventory management, cycle counting, and 

The Director, Engineering Science plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) of the organization. This role assesses and designs processes to integrate new equipment, optimize facilities, and enhance operational capabilities. The Director, Engineering Science leads engineering studies, drives improvements in Drug Substance Manufacturing (DSM), Drug Product and Finished Goods (DPFG), and ensures innovative solutions are implemented effectively. This role is crucial in enhancing site’s process equipment and technology capability offerings and maintaining competitiveness, by making significant...

The QA Engineer, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project 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 Engineer, DSM ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

The Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.

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.

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 Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.   Two Openings