The Automation Engineer 2, CSV will provide support to the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems, and being a part of Automation on-call support as needed. This role will partner with other departments locally and other sites to align strategies and procedures. This role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. Additionally, there will be involvement in facilitating improvement...

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.

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.

The Weigh and Dispense Associate position is responsible for assisting with and executing the set-up, weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role interacts with manufacturing personnel in both Drug Substance and Drug Product teams as well as Warehouse for commercial operations and tech transfer activities required from the Weigh and Dispense operations. This role is responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed. Additionally, there are interim responsibilities associated with a large greenfield start-up, including international travel, performing system user acceptance testing, and setting up the dispensary area for GMP operations.

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 Weigh and Dispense Associate 1 is responsible for assisting with and executing the set-up, weighing of raw materials, solvents, and solutions. This role interacts with both Drug Substance and Drug Product teams as well as Warehouse for commercial operations and tech transfer activities required from the Weigh and Dispense operations. This role is responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed. The Weigh and Dispense Associate 1 is required to work shiftwork, including nights and on-call.

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 Warehouse Associate 3 position will be responsible for storage, handling, and distribution of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance, Drug Product, and Finished Goods products. This role will be supporting Warehouse operations in receiving, shipping, and/or logistics throughout the FDBN facility therefore this candidate will be working with multiple functions to support operations: Manufacturing, Quality, Process Sciences, and other customers as needed. The Warehouse Associate 3 will be using SAP ERP system for inventory management, cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs). This position will require shift...

The Supervisor, Weigh & Dispense is responsible for leading the Weigh & Dispense team and operations within Supply Chain to ensure compliant and reliable production. This position works closely with Raw Material Sampling to flex resources between Weigh & Dispense and Raw Material Sampling, optimizing staffing and productivity. The Weigh & Dispense team consists of multiple shifts in which this supervisor leads and oversees to support the demands of the production schedule, including night shifts, as needed.

About This Role   The QC Sr. Specialist 1, Instrumentation works independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role ensures the performance of routine maintenance, completing periodic reviews of  QC analytical instrumentation to confirm compliance and correct...

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...

As the Senior Director, Process Engineering & Maintenance, this role is responsible for setting the direction and managing central workstreams in the start-up of a $2 billion project. This role leads the process engineering and process maintenance organizations to ensure the successful start-up and ramp-up to meet client commitments ensuring the equipment maintains a state of readiness. Additionally, this role is responsible for designing and implementing manufacturing processes, equipment, and technology while building the team and ensuring flawless execution by leveraging existing experience as a subject matter expert (SME) and people management capabilities in start-up...

The Manager of Compliance & Support, DP develops and oversees the manufacturing support team within the drug product scope. This position ensures compliance by addressing and closing gaps, authoring departmental standard operating procedures (SOPs), creating master batch records in electronic systems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training coordinators. The role also supports...

The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

The Planner 1, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role plans, schedules, and coordinates maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role collaborates with departments across the site to ensure successful completion of work orders.

The Supervisor/Manager, Training & Documentation for Manufacturing Support is responsible for leading the training and documentation team, focusing on the development, implementation, and oversight of comprehensive digital learning programs. This role enhances employee skills, drives organizational performance, and supports the company's digital transformation initiatives in drug substance manufacturing. The Supervisor/Manager, Training & Documentation

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 Senior Director, Digital Process Development and MSAT will lead the strategic direction, full lifecycle management, and continuous improvement of all IT systems and digital capabilities that support Process Development and MSAT. This role is responsible for...

As an integral part of the Global Operation Finance team, the Financial Planning Lead plays a pivotal role in enhancing FUJIFILM Biotechnology’s financial and operational strategy. We are seeking a highly skilled...