Quality Engineer - Computer Systems Validation

Job Title

Quality Engineer – Computer Systems Validation (CSV)

Oxford, UK (Hybrid)

Full-time

Biotech / Genomics / Medical Devices

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.

Reporting directly to the QA Manager – Quality Systems, the Quality Engineer (CSV) ensures all GxP‑relevant computerized systems are validated, maintained, and fully compliant with GAMP 5, 21 CFR Part 11, EU Annex 11, and ISO 13485. The role has full authority to review and approve processes, documents, and records related to design, development, and CSV activities, supporting the complete lifecycle of software and systems across quality, manufacturing, laboratory, and development environments.

• 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.
• GxP System Oversight:
  Provide CSV expertise for eQMS, MES, CRM/ERP platforms, and data acquisition/instrument software.
• Data Integrity & Compliance:
  Enforce ALCOA+ data integrity principles and implement robust controls for electronic records and signatures.
• Change Control & Lifecycle Maintenance:
  Assess system upgrades and configuration changes, executing impact assessments and regression testing to maintain a validated state.
• Vendor &
  
  Risk Management:
  
  Support the qualification of software/cloud vendors and apply risk‑based validation approaches (including Computer Software Assurance – CSA).
• Audits & Inspections:
  Act as the CSV SME during internal, customer, and regulatory inspections, swiftly addressing findings and executing CAPAs.
• Cross‑Functional
  
  Collaboration:
  
  Partner with IT, Digital, Engineering, R&D, and Manufacturing to provide clear CSV guidance and training to system owners.

• B.Sc. degree in Computer Science, Engineering, Life Sciences, or equivalent experience.
• Proven experience in a dedicated CSV role validating computerized systems within a GxP environment.
• Desirable:
  Experience in medical devices, IVD, or pharmaceuticals; formal training/auditing certification in ISO 9001 or ISO 13485.

• Strong, practical knowledge of GAMP 5, FDA 21 CFR Part 11, and the Software Development Life Cycle (SDLC).
• Exceptional technical writing skills with a high attention to detail.
• A collaborative, customer‑responsive attitude with the ability to work independently and influence positive change in a fast‑paced environment.

• Attractive bonus and generous pension contributions.
• Private healthcare.
• Excellent starting salary.

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.