Backed by 500 Global.
About the role
The Senior QA Engineer, Validation helps drive the Quality oversight for Commissioning, Qualification, and Validation (CQV) processes. The position also oversees, reviews, and approves QA validation activities and documents associated with decommissioning, new or modified systems as well as maintenance of the validated state of equipment, processes, and systems. Occasional opportunities for international and/or domestic travel may be available for this role. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Ability to work in a highly regulated environment, adhere to regulatory requirements, and follow Good Manufacturing Practices (GMP)
- Advanced ability to manage multiple assignments, meet deadlines, and balance competing priorities in a fast-paced GMP environment, excellent organization and critical thinking skills with ability to work independently
- High-level understanding of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, Cleaning Development/Verification/Validation, and CQV methodologies
- Ability to support SOP creation, program development, and training curricula to deliver operational and inspection readiness goals
- Excellent communication skills, both written and oral to effectively collaborate cross-function and with department management
- Extensive knowledge of Data Integrity and application of 21 CFR Part 820 and Part 11
More about this role
The Senior QA Engineer, Validation helps drive the Quality oversight for Commissioning, Qualification, and Validation (CQV) processes. The position also oversees, reviews, and approves QA validation activities and documents associated with decommissioning, new or modified systems as well as maintenance of the validated state of equipment, processes, and systems. Occasional opportunities for international and/or domestic travel may be available for this role.
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...
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