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Oversee leave of absence programs to include FMLA; ADA; Pregnancy Worker’s Act; other federal, state, or local-mandated leave; and company leave. Provide operational oversight of third party leave vendor. Administer accommodations programs. Serve as a resource and subject matter expert (SME) on leave management consistent with local, state and federal regulations.
The work location for this exciting opportunity is Holly Springs, NC and will support FLB’s Holly Springs and Morrisville locations.
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The Sr. Operational Excellence (OpEx) Specialist is an experienced, hands-on individual contributor responsible for designing, leading, and sustaining continuous improvement initiatives that improve safety, quality, delivery, cost, and employee engagement across the site and/or network. Leveraging deep Lean Six Sigma expertise (Black Belt) and strong change leadership, this role partners with functional leaders in Manufacturing, Quality, Supply Chain,
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Drive operational excellence across our manufacturing network. In this role, you’ll lead our Continuous Improvement (CI) and 5S programs—governing intake, review, monitoring, and reporting of CI initiatives while delivering hands-on training and coaching to manufacturing teams. You will champion 5S education (sort, straighten, standardize, sustain) across all factories to build a culture of safety, quality, and efficiency.
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The I&C Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with instrumentation and automation systems and controls across the campus. The I&C Engineer provides support for the metrology department through evaluations of instrument deficiencies, test equipment issues and calibration strategies and methods. 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...
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Join a high-impact Quality Control team where you’ll own the lifecycle of critical analytical instruments that keep life-changing therapies moving. As Sr. Specialist 2, QC Instrumentation, you will lead the routine operation, qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation with minimal supervision—while ensuring data integrity and regulatory compliance at every step.
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The Planner 2, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role uses knowledge of maintenance processes and regulatory requirements to plan, schedule, and coordinate maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role seeks opportunities for continuous improvement and collaborates cross-functionally to ensure successful completion of maintenance activities.
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The Supply Chain Compliance Specialist 2, is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support includes initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions to prevent recurrence and drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and...
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The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.
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The Automation Engineer 2, BMS/VDS provides support for the sitewide Building Management System (BMS) and Validated Data System (VDS). This includes implementation of changes to the utility and facility automation systems, updating design documents, executing testing, troubleshooting events, and providing on-call support. This role participates in and may lead projects and medium- to complex-level changes while coordinating with internal and external...
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The Senior, QC Microbiology supports t QC, detecting, and mitigating microbial contamination across facilities, utilities, processes, and products. The roleapplies microbiology principles to validate sterilization, aseptic processing, and cleaning/sanitization; executes environmental and utility monitoring; and ensures compliance with FDA, EU, and global regulatory requirements. This position leads complex testing and data analysis, investigates contamination events and deviations, and partners cross-functionally (Manufacturing, MSAT/Engineering, QA/QC, EHS) to maintain product quality and patient safety. This...
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The Automation Engineer 3, BMS/VDS provides support for the sitewide Building Management System (BMS) and Validated Data System (VDS). This includes implementation of changes to the utility and facility automation systems, updating design documents, executing testing, troubleshooting events, and providing on-call support. This role participates in and may lead projects and medium- to complex-level changes while coordinating with internal and external...
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Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 4 to lead and execute manufacturing processing activities in a cGMP environment. In this senior role, you will support both project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facility—helping ensure safe, consistent, and efficient production of drug substance. You will also assist with daily scheduling and materials oversight for the manufacturing team.
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The Technician 2, Maintenance for Drug Product Finished Goods (DPFG) is responsible for the installation, maintenance, and repair of Drug Product (DP) related systems/equipment (e.g., filling line, automated inspection line, formulation, and isolation). This role ensures the systems meet the stringent requirements of pharmaceutical manufacturing, conducts regular inspections and preventive maintenance DP related equipment to ensure equipment is operating efficiently with minimal downtime.
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Join a high-impact team enabling data-driven manufacturing and development. As our System Administrator for MSAT applications (Manufacturing Science and Technology), you will own, maintain, and continuously improve our analytics and real-time monitoring ecosystem—centered on SIMCA-online, TIBCO Statistica, and Process Analytical Technology (PAT). Your work will ensure our GxP systems are secure, validated, and highly available across global manufacturing and development environments, empowering robust multivariate monitoring, real-time analytics, and confident decision-making. This is not a traditional systems administrator role and will require hands-on...
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The Sr Automation Engineer 1, MES provides support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. Additionally, this role participates in designing and maintain the Manufacturing Execution System (MES).
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The Automation Engineer 3, PLC will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. Specific areas of concentration are PLC controlled equipment such as Water and Steam Generation Skids, Centrifuges, Autoclaves, and Parts Washers utilizing Siemens and Allen-Bradley PLCs and HMIs.
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The Senior Engineer or Scientist of Process Validation ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing, executing, and documenting process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works closely with cross-functional teams to ensure that processes are...
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The Lead Tech of Instrumentation & Controls is responsible for the daily activities within the I&C and Metrology groups. This includes assigning and coordination of calibration and repair activities including project support, as needed across the site. The Lead ensures compliance with all applicable regulatory requirements, including Food & Drug Administration (FDA), current Good Manufacturing Practices (cGMP), and Occupational Safety and Health Administration (OSHA) regulations.
Days and Nights open - 12 hour shifts
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The Automation Engineer 2, DSM, DeltaV Infrastructure, will provide Engineering input on the design, implementation, configuration, and testing/qualification of hardware for an Emerson DeltaV control system. Once in Operations, you will be responsible for and have ownership of the ongoing support of the control system hardware, software, and infrastructure.
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The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.