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
What We’re Looking For…
Education & Experience:
Knowledge, Skills & Attributes:
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.
Our goal is to enable the analysis of anything, anywhere, by anyone.
We have developed the world’s first and only nanopore DNA and RNA sequencing platform. It’s a new generation of sequencing technology — the only one to offer: scalability to portable or ultra-high throughput formats, real-time data delivery, and the ability to elucidate rich biological data.
We are aiming to disrupt the way that biological analyses are currently performed, and open up new applications that have a profound, positive impact on society.
Our devices offer real-time analysis, for rapid insights, in fully scalable formats — from pocket to population scale — and the technology is being used in more than 100 countries worldwide.
Founded in 2005 as a spin-out from the University of Oxford, the company now employs more than 600 people from multiple disciplines including nanopore science, molecular biology and applications, informatics, engineering, electronics, manufacturing and commercialisation. The management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.
