The Senior Maintenance Coordinator supports the day-to-day execution activities within the assigned function (e.g., Maintenance, Instrumentation & Controls, Utility Maintenance, etc.) by facilitating work order readiness, ensuring tool and material availability, managing technician workflow, and serving as a liaison between maintenance, production, quality, and other support teams to maintain optimal equipment performance with minimal downtime. This role influences maintenance protocols, participates in cross-functional initiatives that drive organizational efficiency, and ensures compliance with Current Good Manufacturing Practice (CGMP), safety, and company procedures. Additionally, this role is aligned to specific shifts or provides rotational coverage, as...

The Engineer/Scientist 3 will provide technology transfer support and technical oversight during manufacturing operations

The Engineer/Scientist 2 will provide technology transfer support and technical oversight during manufacturing operations

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 Director, Process Validation plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science and Technology (MSAT) organization. The role responsibilities encompass leading and overseeing all process validation, including material science aspects, to ensure the robustness, efficacy, and compliance of manufacturing processes. his role requires strategic leadership, technical expertise, and cross-functional collaboration to drive continuous improvement and adherence to regulatory standards. The Director, Process Validation is crucial in enhancing the site’s process validation capability offerings and maintaining competitiveness by making...

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...

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.

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 Training Coordinator for Drug Product Finished Goods develops, implements, and oversees training programs for personnel involved in drug product manufacturing, filling, inspection, and packaging operations. This role ensures compliance with cGMP regulations, enhances operational efficiency, and supports continuous improvement initiatives within sterile and non-sterile finished goods production in a 24/7 manufacturing facility

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 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.

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.

This role will lead and execute manufacturing processing steps and associated activities.  This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

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...