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The Director, Product Engineering & Deployment, is responsible for leading the development, delivery and lifecycle maintenance of innovative digital solutions that support biotechnology operations. The role exists to ensure scalable, compliant, and business-value–driven data products are built and deployed across manufacturing, quality, supply chain and other organizational use cases. The position provides technical leadership, cross-functional collaboration, and project execution oversight to enable advanced data-driven decision making, operational excellence, and regulatory compliance in end-to-end biotechnology...
The Sr. IT Engineer 1 is responsible for the support and operation of all IT network infrastructure for the new Holly Springs greenfield site. The engineer will also liaise with Global IT teams to ensure a fit-for-purpose network architecture scaled for a large manufacturing plant. This role functions as a local extension of the Global IT team reporting into the Sr. Director - IT. This role ensures local implementation and support in alignment with global IT processes.
The Sr. IT Engineer 1 is responsible for the support and operation of all IT platform infrastructure for the new Holly Springs greenfield site. The engineer will also liaise with Global IT teams to ensure a fit-for-purpose network architecture scaled for a large manufacturing plant. This role functions as a local extension of the Global IT team reporting into the Sr. Director - IT. This role ensures local implementation and support in alignment with global IT processes.
The IT Engineer 2 – Scientific Systems manages IT instruments like cell counters and microscopes, ensuring these systems remain validated and functional. The role requires ongoing learning of technical aspects to effectively support business needs.
The Director, Data & AI Engineering is responsible for designing, developing, and scaling enterprise data pipelines, and analytics and AI/ML algorithms to create operation efficiencies and create business value. The role ensures that data pipelines, models, and AI/ML engineering frameworks are reliable, secure, compliant, and optimized for business value delivery. This position leads a team of engineers to enable seamless integration of data from biotech systems, support AI/ML lifecycle management, and ensure the organization’s data foundation supports innovation and regulatory compliance.
The Raw Material Sampler 2 position is responsible for sampling of materials and products. This role works with multiple functions to support operations (e.g., Warehouse, Supply Chain, Quality Control (QC)). The Raw Material Sampler 2 uses Systems and Applications Production (SAP) Enterprise Resource
Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).
The QA Specialist, LMS is responsible for collaborating alongside current team members with the creation of curriculum, serving as ComplianceWire administrator, assisting in the continual development of FUJIFILM Diosynth Biotechnologies' education program, co-developer of internal PQS SharePoint site, overall site training ambassador to help encourage, motivating and assisting in meeting deliverables and timelines and more. Works closely with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency.
We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams
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.
Utility Maintenance 2 performs corrective maintenance, routine maintenance, and preventive maintenance on plant utilities equipment following Standard Operating Procedures (SOPs), completes work orders, daily logs and forms following Good Manufacturing Practices (cGMP) documentation practices and quality standards in a Pharmaceutical Manufacturing plant. The corresponding utilities include high-pressure steam boilers, process wastewater treatment, chillers, water purification systems (water softening and carbon bed filtration, reverse osmosis, deionization equipment, sanitary pumps, and associated equipment), compressed air and dryers, and chilled water.
The Senior Production Costing Analyst is responsible for enabling our site to deliver on financial and strategic objectives through forecasting, analysis, and reporting that guide business decisions. This role is integral in managing financial performance and implementing finance strategies to achieve business performance in a cross-functional team environment. The Senior Production Costing Analyst supports the business and drives finance initiatives and decisions. This role is a high performer who exudes a contagious level of positive energy, possesses a high sense of ownership, and has a strong ability to communicate and build rapport with non-financially minded...
The role as Manufacturing Associate 2 will execute and document manufacturing processing activities within a cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
Act as the local Compliance Officer for both of Fujifilm Biotechnologies sites in North Carolina region. In addition, they will be the main Compliance contact / support for any questions / requirements for Fujifilm Biotechnologies.
The Sr. IT Engineer 1, CSV is the Subject Matter Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action items on all GxP Manufacturing and IT Computerized Systems as well as prepares validation documentation, maintains a validated state, with a focus on consistent policy administration. Additionally, this role works closely with other workstreams at FDBN and IT departments at other locations to align strategies and procedures. This role facilitates improvement initiatives, supports regulatory agency, and third-party inspections, as needed.
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 QA Engineer, DSM Operations 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. This role works 12-hour day shift on a 2-2-3 cadence, 0600-1800.
About the Role
The Sr. Specialist 2, QC Program Management Technical transfer (TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 2, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in and leads collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of...
The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role will require working a 12 hour shift on a 2-2-3 Night Shift.
The Associate Director, Data Integration and Reporting leads and drives the manufacturing data architecture design for the global implementation at FUJIFILM Biotechnologies. This role also leads the system life cycle activities for the global implementation of manufacturing data systems, such as historians, and reporting and integration platforms. This role continues to develop as the organization evolves.