The Director, QA Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies North Carolina sites, and globally, as needed. This role serves as the subject matter expert (SME) for regulatory practices and procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists through fostering a culture of growth and development in alignment to organizational goals while collaborating cross-functionally to drive continuous improvement and optimize Regulatory approaches.  

The Engineer 3, Operational Technology (OT) plays a pivotal role with enhancing the OT infrastructure at the Morrisville facility. This role serves as a technical liaison between the Process Automation team and the site to support the maintenance of automation systems, networks, and manufacturing IT systems, troubleshoot events, and provide on-call technical support to a 24/7 facility to ensure seamless operations and continuous improvement.

Associate Director or Director of Program Design will partner with the global commercial sales team, broader commercial organization and site technical/operations teams in support of acquiring new business for Fujifilm Biotechnologies sites. They will lead technical discussions with potential clients projecting Fujifilm experience and expertise in this offering. They will develop and author customer-tailored proposals and assist throughout the sales process

The Strategic Finance Business Partner supports, challenges, and drives long-term strategic priorities, playing a pivotal role in formulating and understanding initiatives that drive long-term financial growth and profitability. This role closely collaborates with Senior Leadership to enhance business performance, conducts detailed analysis to deliver insights, and helps set strategic direction. By blending expertise in finance, strategic analysis, and planning, the Strategic Finance Business Partner guides the company’s Senior Leadership in achieving long-term goals.

The Principal IT/OT Infrastructure and Security Architect will lead the creation and maintenance of the IT/OT roadmaps, and joint strategies for the mission critical infrastructure, this will be based on global alignment with all relevant stakeholders. They with drive the cybersecurity capabilities and roadmaps globally across IT and OT and ensure alignment with established standards such as NIST 800-82, ISA/IEC62443, CIS-20, and ISO27001. 

The Associate 2, Quality Control (QC) Microbiology is responsible for performing routine microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support activities and actively participates in continuous improvement initiatives. 2nd shift.

The Associate 1, Quality Control (QC) Environmental Monitoring (EM) is an entry level position responsible for performing site environmental and clean utility monitoring within the manufacturing classified areas. This role performs routine laboratory testing and support activities in continuous improvement initiatives. 2nd shift