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The Senior Specialist II, QC LIMS is a site-level and cross-functional leader for the Laboratory Information Management System (LIMS), operating with minimal oversight and in accordance with applicable regulatory, corporate, and scientific standards. This role architects, configures, validates, and governs the LIMS platform; plans and executes complex change initiatives; establishes and monitors system health and data integrity controls; and leads continuous improvement and expansion of LIMS capabilities. The Senior Specialist II partners closely with Quality Control (QC), Analytical Development (AD), Manufacturing, Information Technology (IT), and Quality Assurance (QA) to ensure sustained compliance with Good Manufacturing Practice (GMP) requirements, robust data integrity, and business continuity.
The Digital Design Specialist supports Computer Aided Design (CAD) and Building Information Modeling (BIM) technologies by leading the conversion,
governance, and quality of P&IDs and 3D models across operations and capital projects within a Good Manufacturing Practice (GMP) regulated facility.
This role operates autonomously, applying advanced problem-solving to complex models, data and standards while influencing stakeholders with varying
levels of familiarity with CAD and BIM. Additionally, this role works closely with project teams to streamline workflows, enhance data integrity, and support
the successful execution of projects.
The Process Engineer 2 that supports Drug Product Finished Goods (DPFG) within the assigned area(s) [Visual Inspection] provides engineering guidance to stakeholders throughout the organization to support capital projects, technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, compliant with Current Good Manufacturing Practice (CGMP) regulations. This role adheres to product and customer requirements and works toward optimizing plant efficiency and reliability. This role also utilizes their experience with automated systems related to inspection of pharmaceutical products and camera and vision-based inspection systems.
Help power life-changing biologics by orchestrating the heartbeat of our Drug Substance Manufacturing (DSM) operations. As the Production Scheduler, you’ll own the daily and long-term production schedule, drive schedule adherence, and coordinate activities across Maintenance, MSAT (Manufacturing Science and Technology), Engineering, Quality, Supply Chain, and more—keeping people, materials, and equipment moving in sync.
The Manufacturing Science and Technology (MSAT) Engineer 3 provides technical leadership across current good manufacturing practice (cGMP) manufacturing, delivering end-to-end support for scale-up, process validation, continued process verification, and continuous improvement. This role drives technology transfer (TT) of new and existing drug product processes into and between sites, ensuring robust process fit, compliant documentation, and readiness through close collaboration with Process Engineering, Quality Assurance (QA), Quality Control (QC), Supply Chain, and Manufacturing. The Engineer 3, MSAT DPFG provides technical oversight for routine manufacturing operations, including on-floor support, deviation and root-cause investigations, change control, risk assessments, and data-driven performance monitoring, ensuring product quality, compliance, and reliable supply.
The Investigator 1/2 performs minor investigations, identifies root and contributing causes, and contributes to the creation of effective corrective and preventive actions (CAPAs) while ensuring timely closure of assigned investigations. This role also supports senior investigators with major investigations and other tasks, as needed.
Help build and sustain reliable, compliant manufacturing at a world‑class, 24/7 biomanufacturing site. As a Manufacturing Specialist I, Materials, you will be a key driver of operational readiness, daily production excellence, and continuous improvement. This role supports a round‑the‑clock operation and may require flexibility with working hours and shift rotation.
The Automation Engineer 3, DSM PI Data Historian, will provide Engineering input on the design, implementation, configuration, and testing qualification of the 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.
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.
Join a high-impact team that keeps life-changing biopharmaceutical manufacturing running smoothly. As a Material Handler, you’ll be the engine behind safe, compliant, and efficient material flow across GMP cleanroom environments—ensuring production teams have exactly what they need, when they need it. If you thrive in a fast-paced, highly regulated setting and take pride in precision, this is your moment.
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.
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 documentation for associated system deficiencies.
The Lead Warehouse Associate position is responsible for storage, handling, and distribution of materials and products. This role leads and supports the
Warehouse operations team in receiving, shipping, and/or logistics. The Lead Warehouse Associate works closely with multiple areas to support
operations (e.g., Manufacturing, Quality, Process Sciences, and other customers) as needed. This role uses SAP ERP system for inventory management,
cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs). This position requires shift work and
weekend hours to support operations and is required to fulfill on-call responsibilities, as needed.
The Analyst, QC Microbiology is responsible for the key operational aspects of the QC Microbiology laboratory. This role performs microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples under minimal supervision. The Analyst, QC Microbiology is responsible for all activities associated with testing in accordance with written procedures. This role participates in writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff, as needed and in addition to regular work duties and assignments.
Make a direct impact bringing lifesaving therapies from partner sites to GMP manufacturing. As a Manufacturing Specialist – Tech Transfer, you will lead and execute end-to-end drug substance tech transfers from external partners/CMOs into our site, coordinating cross-functional activities, ensuring process and documentation readiness, supporting scale-up and validation (PPQ), and enabling efficient, compliant start-up of commercial or clinical production.
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.
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 stakeholders.
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