Computer System Validation (CSV) Engineer III

Kyowa Kirin North America(25 days ago)

Sanford, NCOnsiteFull TimeSenior$106,300 - $138,800Quality/Validation

About this role

The CSV Engineer will support commissioning, qualification, and computer system validation activities for Kyowa Kirin’s Sanford, NC manufacturing facility, with an initial focus on LIMS implementation and instrument integrations. This individual contributor role reports to the Site EQV/CSV Lead and will transition to ongoing EQV/CSV support and maintenance as the site moves into routine operations. The position emphasizes collaboration and adherence to regulatory and company quality standards.

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Required Skills

CSV
EQV
LIMS
Veeva
D365
MES
PCS
BMS
Data Historian
ValGenesis

+10 more

Qualifications

Bachelor's Degree in Technical Field
GMP Training
Safety Training

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.