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The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing, including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
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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.
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The Tech 1, Instrumentation & Controls (I&C) role is responsible for ensuring the efficiency and operational reliability of the instrumentation and controls that support facility-wide equipment, and facility systems through effective Corrective and Preventive (CAPA) Maintenance and Calibration practices and know-how.
Days and Nights open - 12 hour shifts
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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.
Days and Nights open - 12 hour shifts
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The Associate Director, QC Biological is responsible for management of multiple labs within the Quality Control department including QC Microbiology. The individuals will act as a representative of QC in cross functional meeting focusing on both startup activities and routine operations. The leader will be responsible for hiring plans, budget development, strategic planning, and driving results. This role plans, schedules, and oversees multiple QC laboratories in order to drive compliance goals, schedule adherence, profit plans, and strategy objectives of the company and the department. The Associate Director, QC Biological identifies operational needs for special projects (new product...
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The Supervisor of Instrumentation & Controls (I&C) is responsible for overseeing and coordinating the operational reliability of the site instruments through an effective calibration process. This role focuses on maintaining and manages equipment, processes, and daily activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practice (GMP) standards. Additionally, the Supervisor provides training, technical support, and leadership to the I&C team.
Night Shift
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The Master Technician for Maintenance is a senior-level hands-on maintenance professional responsible for the installation, troubleshooting, repair, and reliability of critical process and utility equipment within a Good Manufacturing Practice (GMP) pharmaceutical manufacturing environment. This role serves as a subject matter expert (SME) in mechanical systems, including rotating equipment, hygienic process systems, valves, pumps, and clean utility infrastructure while providing technical expertise and guidance to junior technicians and other stakeholders. The Master Technician executes precision maintenance activities, leads complex mechanical troubleshooting, ensures equipment is maintained in a validated and inspection-ready state; in addition to emphasizing...
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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 stakeholders.
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The Automation Engineer, MES, provides support to the Drug Substance Manufacturing (DSM) facility. This includes implementing changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being part of the automation on-call support. This role will lead projects and handle complex changes while coordinating with other internal and external groups.
Openings available from entry-level to senior engineers. Join us and grow your automation career.
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The Technician 3, HVAC 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.
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This is a day shift position supporting our 2/2/3 schedule from 6am-6pm.
The Utility Operator 2 operates, maintains, and repairs black and clean utility systems. This position is also responsible for monitoring...
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The Automation Engineer 2, 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, DSM Upstream, will provide support to the Drug Substance Manufacturing (DSM) facility using DeltaV. This includes implementing changes to the Automation systems, updating design documents, executing tests, troubleshooting events, and providing automation on-call support. This role focuses on supporting the delivery of DeltaV logic for Upstream process areas, including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.
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The Automation Engineer, Downstream 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. This role focuses on supporting the delivery of DeltaV logic for Downstream process areas including Buffer Preparation/Hold, Purification – Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing.
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The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing, including training new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
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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.
multi openings
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The Technician 1, Maintenance is responsible for assisting 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.
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The Supervisor, Visual Inspection supports start-up and operational activities. This role leads a shift team supporting a 24/7 operating facility. The Supervisor, Visual Inspection oversees daily manual and automated Visual inspection operations for Drug Product in a Good Manufacturing Practices (GMP) regulated environment. This role ensures inspection activities meet regulatory, quality, safety, and production requirements while leading and developing inspection personnel. This role is integral in defect detection, compliance, continuous improvement, and inspection readiness.
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This Utility Operator 3 position supports our night shift. This is a 2/2/3 work schedule from 6pm-6am.
The Utility Operator 3 operates, maintains, and repairs black and clean utility systems. This role is also...
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The Sr. Analyst 1, QC Sample Control works independently with limited supervision and guidance from their manager to ensure all samples managed by the Sample Control team are handled and documented in accordance with applicable internal procedures. This role is responsible for handling samples manufactured at FDB Holly Springs, samples and reference materials from external sources, coordinating stability samples and protocols within the sample control team. This role is also responsible for coordinating with key internal stakeholders on the transport of QC samples from Holly Springs to external testing laboratories and support continuous improvement projects and SOP revisions by providing input into...