Senior Quality Assurance Engineer, Technology Transfer

Position Overview Join us as a Senior Quality Assurance Engineer specializing in Technology Transfer, where you will play a crucial role in establishing and running an efficient Technology Transfer program. Based in Holly Springs, NC, you'll focus on maintaining high-quality and compliance standards throughout the Technology Transfer lifecycle and ensure seamless collaboration across departments such as Manufacturing, Supply Chain, Quality Control, and more. Company Overview FUJIFILM Biotechnologies is dedicated to revolutionizing bioproduction. By the end of 2025, we are set to launch North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, providing comprehensive drug substance production, fill-finish, and packaging services. If you're passionate about transforming healthcare and making a difference through your work, we invite you to join us in our exciting mission to develop the next life-saving therapies. The Holly Springs, North Carolina location combines a welcoming community feel with the vibrant tech scene of nearby Raleigh, offering an ideal balance of personal and professional opportunities. What You'll Do As part of our team, you will: Develop and uphold systems to ensure compliance with GxP standards relevant to Technology Transfer activities. Define and understand Technology Transfer processes, utilizing data and technology to enhance efficiency and monitoring. Integrate Technology Transfer processes with other Quality Systems, such as Deviation/CAPA, Change Control, and Validation. Oversee cGMP activities in support of Technology Transfer deliverables, including the development of gap assessments and process controls. Review and approve new manufacturing documents, validation protocols, and relevant entries in our systems. Communicate the progress and quality metrics of Technology Transfer activities to management. Collaborate with cross-functional teams to ensure timely and accurate completion of Technology Transfer milestones. Review and provide input on critical deviations, CAPAs, and change controls related to Technology Transfer. Act as a subject matter expert for Technology Transfer during interactions with regulators, clients, and internal management. Support senior management with departmental tasks and initiatives. Perform additional responsibilities as needed. Minimum Requirements: To be considered for this position, you should have: A Bachelor's degree in Life Sciences or Engineering with 8+ years of relevant industry experience, or A Master's degree in Life Sciences or Engineering with 6+ years of experience, or A PhD in Life Sciences or Engineering with 4+ years of experience. Previous experience in Technology Transfer and a solid understanding of GMP environments are essential. Preferred Qualifications: We value candidates who also have: Familiarity with validation software such as Smartsheet, Trackwise, MasterControl, Veeva, or Kneat. Knowledge of upstream cell culture, large-scale recovery, and aseptic processing. Strong organizational skills and the ability to manage complex projects within deadlines. Understanding of manufacturing equipment, quality systems, and validation methodologies. Insights into Data Integrity and compliance with 21 CFR Part 820 and Part 11. Experience or training in Quality Risk Management principles. Physical and Work Environment Requirements: This role may require: Ascending or descending ladders, scaffolding, and ramps. Prolonged standing (up to 30 minutes) and sitting (up to 120 minutes). Occasional lifting of objects up to 10 pounds. EEO Information Fujifilm is committed to equal opportunity without regard to nationality, age, gender, or any other characteristic. ADA Information If you require reasonable accommodation for the application process or subsequent stages, please reach out to our HR Department.