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.

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.

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 Technician 2, HVAC/Refrigeration is responsible for the installation, maintenance, and repair of the heating, ventilation, air conditioning, and refrigeration systems/equipment. This role ensures these systems meet the stringent requirements of pharmaceutical manufacturing and storage environments. Additionally, this role is responsible for conducting regular inspections and preventative maintenance on HVAC/R systems to ensure they are operating within the required specifications.

The Weigh and Dispense Associate position is responsible with assisting and executing in the set-up, and weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role will interact 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 will be responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed.  

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 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

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 will operate, maintain, and repair black and clean utility systems. This position will also be 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. This role will also be responsible for daily monitoring of tank farm, supporting lab admin building, building management system (BMS) and critical alarm response.  

The Utility Operator 3 operates, maintains, and repairs black and clean utility systems. This role is also responsible for monitoring mechanical and/or electrical equipment, power distribution, chilled water, gas, domestic and de-ionized water, WFI, clean 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. This role serves as the primary contact and communicator to all alarms received in the control room.  

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 have multi positions open- days and nights shift      

The Technician 2, 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 have multi positions open- days and nights shift    

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 Senior Clean Utilities Engineer is the Subject Matter Expert (SME) and 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 provides ownership for the assigned clean utility systems and partners with other stakeholders in the operation of owned systems. This role works directly with other Utility Engineers to ensure applicable safety and regulatory standards are maintained, identify process improvements, and assist with troubleshooting equipment issues to maintain overall plant reliability. Additionally, this role...

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...