Job Description
Quality Engineer – Computer Systems Validation (CSV)
Location: Oxford, UK (Hybrid)
Position Type: Full-time
Sector: Biotech / Genomics / Medical Devices
About Us
Oxford Nanopore Technologies is a global leader in nanopore-based next-generation sequencing, delivering innovative research and IVD products worldwide. Operating within a strict GxP environment, we ensure our cutting‑edge technologies meet the highest global regulatory standards.
The Role
Reporting directly to the QA Manager – Quality Systems, the Quality Engineer (CSV) plays a fundamental role in ensuring all GxP‑relevant computerized systems are validated, maintained, and fully compliant with GAMP 5, 21 CFR Part 11, EU Annex 11, and ISO 13485.
You will have full authority to review and approve processes, documents, and records related to design, development, and CSV activities.
This role supports the complete lifecycle of software and system...