Quality Engineer, FUME Lead (QS&C)

Kyowa Kirin North America(3 days ago)

Sanford, NCOnsiteFull TimeSenior$129,000 - $193,500Quality Systems & Compliance

About this role

Kyowa Kirin is seeking a Quality Engineer, FUME Lead to oversee quality and compliance during the startup and operation of its new GMP manufacturing site in Sanford, NC. The role involves developing quality engineering processes for facilities, utilities, maintenance, and equipment to ensure regulatory compliance and inspection readiness.

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Required Skills

GMP
Validation
Change Control
Calibration
Risk Assessment
Inspection Readiness
Utilities
Facilities
Quality Engineering
Asset Management

Qualifications

Bachelor’s degree in engineering or science

About Kyowa Kirin North America

kyowakirin.com

Kyowa Kirin is a Japanese biopharmaceutical company that develops innovative specialty medicines, with a particular focus on antibody‑based therapies for cancer, kidney disease, and immune‑mediated disorders. The company pursues technology‑driven drug discovery across biologics and small molecules and maintains a broad global network of research, development, and commercial operations. Kyowa Kirin advances a pipeline through internal R&D and strategic partnerships (including biologics and CDMO collaborations) to bring life‑changing treatments to patients. It emphasizes patient‑centred value, scientific expertise, and sustainability in its mission to raise health and well‑being worldwide.

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