QA Engineer, DSM Operations - Nights

Fujifilm•Holly Springs, NC

23h•Onsite

About The Position

The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

BS/BA in Life Sciences or Engineering or equivalent with 6+ years of applicable industry experience OR MS in Life Sciences or Engineering and 4+ years of applicable experience OR PhD in Life Sciences or Engineering and without any experience
3+ years of experience in GMP Quality Assurance and/or similar role
Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11

Nice To Haves

Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
Experience with startup projects or initiatives
Occasional opportunity for International and/or Domestic travel may be available
Training and/or familiarity with Quality Risk Management principles

Responsibilities

Perform an SME role within the QA team for the development of documents, processes, and procedures for the DSM program (Working Schedule: 1800-0600 in a 2-2-3 cadence, eligible for shift differential)
Per applicable procedures, provides QA support of tasks such as BPR review, event triage, DR/CAPA review and approval, area changeover and release and WO oversight
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 documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility
Ensures operational quality objectives are met within desired timelines
Participates in optimization or improvement initiatives
Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
Perform other duties as assigned