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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.
we have multi positions open- days and nights shift
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.
we have multi positions open- days and nights shift
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.
Working nights Mon-Fri 8pm to 4am.
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 significant contributions to the company’s growth and innovation.
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 initiatives and supporting regulatory agency and third-party inspections.
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. This role ensures local implementation and 24/7 support in alignment with global support processes.
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 shipping activities while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).
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 deviations and excursions. The role supports stakeholders with issues and guidance related to QC analytical instruments. This role is included in routine on-call and weekend support, as needed.
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