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.   Tech 2, Maintenance -  night shift - 6PM to 6:30AM- 3-2-2-3- rotating shift

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.      

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.   Days and Nights open - 12 hour shifts

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.

The Senior Manufacturing Execution System (MES) Specialist owns the end-to-end design, configuration, testing, and lifecycle support of electronic Master Batch Records (eMBRs) within PAS-X. This role ensures eMBRs align with manufacturing process requirements, cGMP/regulatory standards, and digital integration objectives, driving continuous improvement and compliance. The Sr. MES Specialist scopes work, sets priorities, and delivers solutions for electronic batch execution in drug product manufacturing, engaging cross-functional stakeholders only as needed to meet timelines and quality standards.

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...

The PAT Senior Engineer leads the design, integration, and lifecycle management of Process Analytical Technology (PAT) solutions across development and GMP manufacturing. Partnering with MSAT, Automation/Engineering, QA/CSV, and IT/OT, this role deploys sensors, analyzers, and models to enable real‑time monitoring, multivariate analytics, and advanced process control (APC). The incumbent establishes enterprise standards, orchestrations, and data flows that are compliant with cGxP and data integrity requirements, accelerating technology transfer, improving process robustness, and supporting Continued Process Verification (CPV). Operates with minimal guidance and influences...

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...

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

The Automation Engineer 2 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).

 The HVAC Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with air handling systems for building environmental control as well as GMP clean rooms. The HVAC Engineer provides support for cold rooms and freezers on site working with other discipline engineers and HVAC technicians. 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 Electrical Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with plant electrical systems from 24kV to 120VAC systems, including Uninterruptible Power Supplies, Fire Protection Systems and Site elevators. The Electrical Engineer interfaces with the electric utility provider, as needed to maintain the reliability of power to the campus. This role utilizes their knowledge of electrical distribution systems, voltage and short circuit studies and current NEC codes. 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...

The Manager of CQV enables efficient tech transfer and new product introductions at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and on-time commercial production. This role provides technical expertise to the immediate team and other stakeholders, as needed. Additionally, this role leads a team of Engineers and provides coaching and direction.

The Project Manager 2 is responsible for collaborating with internal and external stakeholders, including but not limited to Environmental, Health & Safety(EHS), Maintenance, contractors, vendors, and clients. This role is responsible to handle administrative aspects of the project from start to completion, track and monitor the project status and milestones, and ensure projects meets all standards, timelines, and budgets.

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

The Manager, Compendial Testing is accountable for cGMP compliant laboratory operations according to GMP guidelines. This role manages and supervises the QC Compendial Testing team performing testing according to USP/EP/JP guidelines to support drug substance and drug product manufacturing processes. The Manager, Compendial Testing provides managerial support for troubleshooting of complex investigations and optimizing laboratory systems and ensures the laboratory is maintained in a state of cGMP compliance. This role is the technical subject matter expert (SME) and participates in assessing the testing of compendial methods and...

The Technician 2, 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.

The Quality Control Virology Scientist II is a technical subject matter expert (SME) responsible for the QC analytical methods requiring aseptic technique including viral infectivity assays, mammalian cell culture, growth and purification of viral stocks, titering of viral stocks and PCR based methods.  The QC Virology Scientist II will ensure GMP compliant laboratory operations in accordance with regulatory guidelines.  This role will perform technical/compliance reviews and approve analytical results. The role will also approve laboratory exceptions, invalid assays, deviations, change controls and corrective and preventative actions...

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.

The Senior Specialist 1, Quality Control Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both...