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 systems used across quality, manufacturing, laboratory, and development environments—ensuring data integrity is uncompromised and systems are consistently fit for purpose.
Key Responsibilities
1. Validation Lifecycle Management: Plan, execute, and maintain validation activities (VP, URS, FS/DS, Risk Assessments, and IQ/OQ/PQ protocols) in line with GAMP 5 principles.
2. GxP System Oversight: Provide CSV expertise for electronic Quality Management Systems (eQMS), manufacturing systems (MES), CRM/ERP platforms, and data acquisition/instrument software.
3. Data Integrity & Compliance: Enforce ALCOA+ data integrity principles and implement robust controls for electronic records and signatures.
4. Change Control & Lifecycle Maintenance: Assess system upgrades and configuration changes, executing impact assessments and regression testing to maintain a validated state.
5. Vendor & Risk Management: Support the qualification of software/cloud vendors. Apply risk-based validation approaches (including Computer Software Assurance - CSA).
6. Audits & Inspections: Act as the CSV Subject Matter Expert (SME) during internal, customer, and regulatory inspections, swiftly addressing findings and executing CAPAs.
7. Cross-Functional Collaboration: Partner with IT, Digital, Engineering, R&D, and Manufacturing to provide clear CSV guidance and training to system owners.
What We’re Looking For…
Education & Experience:
8. B.Sc. degree in Computer Science, Engineering, Life Sciences, or equivalent experience.
9. Proven experience in a dedicated CSV role validating computerized systems within a GxP environment.
10. Desirable: Experience in medical devices, IVD, or pharmaceuticals; formal training/auditing certification in ISO 9001 or ISO 13485.
Knowledge, Skills & Attributes:
11. Strong, practical knowledge of GAMP 5, FDA 21 CFR Part 11, and the Software Development Lifecycle (SDLC).
12. Exceptional technical writing skills with a high attention to detail.
13. A collaborative, customer-responsive attitude with the ability to work independently and influence positive change in a fast-paced environment.
Why Join Us?
Apply today to take ownership of vital quality systems and support the delivery of technologies transforming genomics and diagnostics globally.
We offer outstanding benefits to include an attractive bonus, generous pension contributions, private healthcare and an excellent starting salary.
If you are looking to utilise your skills to really make a difference to humankind, then consider joining our team and apply today