The Warehouse Associate 2 position is responsible for storage, handling, and distribution of materials and products. This role supports Warehouse operations in receiving, shipping, and/or logistics throughout FDBN and works with multiple functions to support operations (e.g., Manufacturing, Quality, Process Sciences), The Warehouse Associate 2 uses Systems Applications and Products (SAP) ERP system for inventory management, cycle counting, and shipping activities while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).

Standard work hours for this position are 10AM-6:30PM ET. You may also be subject to shift work in the future.

The Supervisor, Drug Product Filling supports start up and operational activities for the site. This role leads a shift team and isresponsible for the manufacturing process and facility which will eventually operate 24/7 model.

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 Director, Project Engineering is responsible for overseeing the development of the engineering design and execution of construction design administration to support Fujifilm’s $3.4B expansion in Holly Springs, North Carolina. This role provides leadership for all engineering focused initiatives and activities, and monitors project milestones and achievements to ensure successful completion of project scope within the defined or adjusted parameters. Additionally, this role collaborates extensively with internal and external stakeholders ensuring that lessons learned are provided promptly and that the right people are assigned the right tasks providing challenge and enhancement to their skills.

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 Associate Director, QC Analytical is responsible for management of the QC Analytical technology centers of excellence, including hiring plans, budget development, strategic planning, and driving results. This role plans, schedules, and oversees laboratory activities related to meeting compliance, schedule adherence, profit plans, and strategy objectives of the company and the department. The Associate Director, QC Analytical identifies operational needs for special projects (new product sub-team, capital projects, etc.) - ensuring site/divisional linkage is achieved. This role identifies and addresses short term, intermediate, and long-term issues in a satisfactory manner, and appropriately resolves conflict and prioritizes work as necessary. The Associate Director, QC Analytical may have managers, supervisors, individual contributors, and hourly support staff reporting to them.

The QA Project Manager, Program Quality Assurance (PQA) is responsible for providing the PQA team with assistance and oversight of QA projects. As projects evolve and startup activities develop, this position adapts its responsibilities to meet changing needs. The QA Project Manager, PQA focuses on establishing, facilitating, and delivering key performance indicators (KPI), continuous improvement and risk management activities in support of site readiness for operations, start-up and ongoing operations. This role is responsible for administering policies, and effectively addressing and mitigating any issues encountered during assigned activities. 

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 project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

The Manufacturing Support Associate 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.  

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 Associate Director, Digital Manufacturing leads and drives the Recipe Driven Operation (RDO) design for the global implementation at FUJIFILM Biotechnologies. This role also leads the global technology transfer activities and standards definition as they relate to Automation while defining and supporting the governance for life cycle of RDO and Configuration Environment for Batch Activities (CEBA). This role continues to develop as the organization evolves.

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

This role performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.   

The Automation Engineer 3, DSM 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.