QA Engineer, DSM Operations
About The Position
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 (Days). FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”
Requirements
- BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR MS in Life Sciences or Engineering and 3+ years of applicable experience OR PhD in Life Sciences or Engineering and with 1+ years of applicable experience
- 3+ years of experience working in a GMP regulated environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Nice To Haves
- Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
- Experience with startup projects or initiatives
Responsibilities
- Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program
- Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation
- Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
- Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in a cGMP-regulated facility
- Ensures project and operational quality objectives are met within desired timelines
- Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
- Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections
- Works 12-hour shift on 2-2-3 cadence, 0600-1800
- Performs other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
