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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
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The Lead Associate 3, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively trains junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.
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The Supervisor, QC Microbiology leads a team of microbiology analysts to execute GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing. This role ensures cGMP compliance, data integrity, safety, and right first-time performance, while driving method robustness, investigation quality, and continuous improvement. The Supervisor typically supervises staff and junior scientists, manages day-to-day operations, and contributes to cross functional initiatives of moderate complexity.
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The Quality Control group at FDBU group is seeking a Lead QC Associate II – Raw Materials at our Bioprocess Innovation Center in Morrisville, NC. The QC Lead Associate II is responsible for sampling, testing, and releasing incoming raw materials in compliance with GMP, regulatory standards (USP/EP/JP), and internal quality procedures. This role ensures materials meet specifications prior to use in manufacturing and supports data integrity, documentation, and continuous improvement within the Quality Control laboratory.
Shift: Monday – Friday...
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The Senior QA Engineer, Validation helps drive the Quality oversight for Commissioning, Qualification, and Validation (CQV) processes. The position also oversees, reviews, and approves QA validation activities and documents associated with decommissioning, new or modified systems as well as maintenance of the validated state of equipment, processes, and systems. Occasional opportunities for international and/or domestic travel may be available for this role.
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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 Scientist 1, QC Analytical Development Chemistry supports the transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. This role ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. The Scientist 1, QC Analytical Development Chemistry authors transfer documents and executes testing as part of transfer for the following analytical methods: HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map); UVA280 and slope spectroscopy; capillary electrophoresis (CE-SDS, imaged capillary...
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The Analyst 1, QC Compendial Testing ensures laboratory operations are good manufacturing practices (GMP)-compliant according to United States\Europe\Japan pharmacopeia (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following TT activities, the position performs material testing and disposition using the established analytical methods.
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The Scientist 1, QC Compendial Testing participates in the Technology Transfer (TT) of material methods into the FUJIFILM Biotechnologies, Holly Springs Quality Control Laboratory, with limited supervision. This includes the onboarding of new and generic raw materials as part of new customers/programs. This role provides assessments, identifies QC compendial testing requirements and executes action items as part of change controls for the onboarding of these materials based on vendor documentation. This position also identifies materials together with customers in a cross functional team as well as provides technical knowledge to assess testing approach, verification and validation needs both...
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The Senior Analyst 1, QC Compendial Testing ensures laboratory operations are Good Manufacturing Practices (GMP)-compliant according to United States/Europe/Japan (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the Quality Control Laboratory as well as performs material testing and disposition using the established analytical methods.
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The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). The role executes MSAT strategy, builds and develops a team of scientists and engineers, and optimizes large scale cell culture operations across seed/production bioreactors and purification trains. With a focus on innovation and reliability, this leader drives technical stewardship through tech transfer execution, process performance qualification (PPQ) execution, commercialization, as well as continuous improvement initiatives. This leader partners closely with the rest of the MSAT leadership team, Manufacturing, QA, Automation, and...
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The Senior People and Culture Operations Partner serves as the main point of contact and resolution for all PNC queries, including Workday and policy advice in line with best practice, from employees, managers and leaders. This roles This position also assists with Business Partner activities to support an engaged workforce.
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The MRO Specialist under the supervision of the Sr. Manager Facilities Support Operations
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The Maintenance Technician I, under the supervision of the Facilities Maintenance
Supervisor, or designated supervisor will be responsible for performing various aspects of utilities,
facilities and process equipment maintenance and support for the Texas Biological Facility (TBF),
the Flexible Biological Facility (FBF) and the National Center for Therapeutic Manufacturing
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The Finance Business Partner is a critical role that delivers strategic financial insight and decision support to functional and site leaders, enabling performance management across the contract manufacturing portfolio. This role leads planning, budgeting, and forecasting cycles; develops management reporting and variance analysis; and translates operational drivers into actionable financial plans while ensuring adherence to IFRS, company policies, and industry-specific financial practices. The position requires exceptional organizational skills, strong FP&A and commercial finance acumen, and outstanding communication to influence cross-functional stakeholders. The successful candidate...
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The Process Engineer 1 will provide engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.
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The Engineer 2, Black Utilities provides engineering support to field personnel in the performance of maintenance and operational tasks associated with
Black Utilities, including HVAC systems, Chilled Water Systems, Steam Boilers, Cooling Towers, HVAC and Glycol Chiller and Compressed Air Systems. This
role works directly with other Utility Engineers to ensure applicable safety and regulatory standards are maintained, identify process improvements, and
assist with troubleshooting equipment issues to maintain overall plant reliability.
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The Senior 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 Senior Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.
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The Associate Director (AD), Program Quality Management is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The Associate Director, Program Quality Management works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and...
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The Engineer, QA Drug Substance Manufacturing is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues.