Quality Engineer - Computer Systems Validation

Quality Engineer – Computer Systems Validation (CSV)

Location: Oxford, UK (Hybrid)

Position Type: Full-time

Sector: 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.

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

• 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 electronic Quality Management Systems (eQMS), manufacturing systems (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. Apply risk-based validation approaches (including Computer Software Assurance - CSA).
• Audits & Inspections: Act as the CSV Subject Matter Expert (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.

What We're Looking For.

Education & Experience

• 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.

Knowledge, Skills & Attributes:

• Strong, practical knowledge of GAMP 5, FDA 21 CFR Part 11, and the Software Development Lifecycle (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.

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

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.

#LI-JC1

Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.