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Senior Employee Relations Partner is critical in supporting managers and leaders to maintain a fair, harmonious workplace that supports organizational goals. Senior ER Partner will have current employment law knowledge and will manage and deliver a caseload of employee relations cases. In addition to upskilling managers on the management of
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The QA Engineer, Validation is responsible for helping to drive the Quality oversight for commissioning and qualification processes. This role is responsible for quality assurance oversight, review, and approval of validation activities and documents associated with new systems, changes to existing systems, maintaining the validated state of equipment/processes/systems, and decommissioning.
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The QA Specialist, DSM Operations (Days 2-2-3 0600-1800) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, DSM Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
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The Lead Technician, Maintenance is responsible for the installation, maintenance, and repair of process related systems and equipment. This includes ensuring the associated systems meet the stringent requirements of pharmaceutical manufacturing. The Lead is also responsible for conducting regular inspections and preventive maintenance on process related equipment to ensure equipment is operating efficiently with minimal downtime while complying with all applicable regulatory requirements, including Food & Drug Administration (FDA), Current Good Manufacturing Practice (CGMP), and Occupational Safety and Health Administration (OSHA).
This position is a 2-2-3-day shift 12...
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The Lead Security Systems Specialist is responsible for the efficient and effective maintenance and repair of security systems in a safe, reliable, economical, & environmentally sound manner. The Security Equipment Specialist owns an effective preventive, predictive, and corrective security maintenance program. This role carries out duties in a professional manner including the use of the Human Performance Tools, Safe Work Practices and Procedure Use
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The Quality Control Sample Control Analyst works under the 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 Fujifilm Biotechnologies and samples and reference materials from external sources. This role is primarily responsible for collecting and aliquoting samples. This role is also responsible for coordinating with key internal stakeholders the transport of QC samples from Fujifilm Biotechnologies to external testing laboratories and support continuous improvement...
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Do you thrive in a fast-paced, highly regulated environment where precision, teamwork, and continuous improvement make a real difference for patients? Join our Drug Product team as a Manufacturing Associate III to lead hands-on operations across formulation, sterile filling, and visual inspection—while helping stand up and optimize a state-of-the-art DP facility.
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Join a high-growth biomanufacturing site and help ensure safe, compliant, and reliable production. As a Manufacturing Specialist I, you’ll be a hands-on problem solver who supports day-to-day operations, documentation, and continuous improvement—keeping batches on plan and the plant audit-ready.
You’ll be the go-to partner for manufacturing operations: coordinating batch readiness, improving templates and documents, resolving issues on the floor, and driving compliance activities that keep our products moving to patients.
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Help build and optimize a best-in-class LabWare LIMS v8 environment that powers Quality Control in a GMP setting. As Sr. Specialist 1, QC LIMS, you’ll configure, validate, and sustain a critical system that enables compliant, efficient testing—directly impacting product quality and patient safety.
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The Director, Quality Systems and Compliance provides strategic leadership for the site's Pharmaceutical Quality System (PQS), Audits and Inspections, Documentation Management, GxP Learning, and Quality Compliance programs. The role ensures sustainable inspection readiness, maintains compliance with global regulatory requirements, and drives continuous improvement across quality systems. The Director serves as a key site leader during customer audits and regulatory inspections and partners across functions to strengthen quality culture, data integrity, and operational excellence. The Director, Quality Systems and Compliance fosters a strong Quality Culture across teams and contributes to cohesive...
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The Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures FUJIFILM Biotechnologies, Holly Springs provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FUJIFILM Biotechnologies, Holly Springs Quality. The Program Quality Manager handles and/or supports an average load of 1-3 client programs.
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The Senior People & Culture Coordinator drives and coordinates the onboarding process for all new and transferring employees. This highly visible role liaises with cross-functional departments within and outside of the NC Region. The Senior PNC Coordinator manages multiple administrative priorities, competing deadlines as well as recurring and non-routine PNC processes.
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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.
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The Senior Project Manager, Strategy & Execution leads high-impact, cross-functional projects and strategic initiatives that advance the site’s operational and business strategy. This role sets the standard for project management excellence and cross-functional collaboration, translating strategy into executable roadmaps, establishing governance and delivery discipline, and ensuring benefits realization. The position partners closely with Site Leadership and functional leaders (Operations, Quality, EHS, Supply Chain, Finance, IT, HR) to prioritize, plan, and deliver...
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The Senior Project Manager, Strategy & Execution leads high-impact, cross-functional projects and strategic initiatives that advance the site’s operational and business strategy. This role sets the standard for project management excellence and cross-functional collaboration, translating strategy into executable roadmaps, establishing governance and delivery discipline, and ensuring benefits realization. The position partners closely with Site Leadership and functional leaders (Operations, Quality, EHS, Supply Chain, Finance, IT, HR) to prioritize, plan, and deliver...
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Make a meaningful impact at the intersection of biomanufacturing and digital operations. If you’re excited to learn and grow while supporting cGMP production with modern tools like MES, data historians, and electronic logbooks, this role is a great entry point into a high-impact, highly collaborative environment.
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The Sr. Analyst 1, Quality Control (QC) All QC Team is responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC.
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Build life-changing medicines with a team that trusts you to lead on the manufacturing floor. As a Manufacturing Associate 3 (Drug Substance Manufacturing), you’ll take ownership of critical processing steps, help bring new capacity online, and keep a 24/7 operation running safely, compliantly, and on time. If you thrive in hands-on, fast-paced environments and enjoy guiding others, this is your next step.
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Help deliver safe, high-quality medicines at scale. As a Manufacturing Associate 3, Drug Product, you’ll play a hands-on role in component/parts preparation, thawing and formulation, sterile filling, and visual inspection—supporting a 24/7 operation that keeps patients at the center.
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The Technician 3, 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.
we are hiring for multiple positions across day and night shift