At a Glance
- Tasks: Ensure GxP computerized systems are validated and compliant with global standards.
- Company: Join Oxford Nanopore Technologies, a leader in innovative biotech solutions.
- Benefits: Enjoy competitive salary, bonuses, private healthcare, and generous pension contributions.
- Other info: Collaborative culture with opportunities for professional growth and development.
- Why this job: Make a real impact on genomics and diagnostics while developing your career.
- Qualifications: B.Sc. in Computer Science or related field; experience in CSV within GxP environments.
The predicted salary is between 40000 - 50000 £ per year.
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
- 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.
Quality Engineer - Computer Systems Validation in Oxford employer: Oxford Nanopore Technologies
Oxford Nanopore Technologies is an exceptional employer, offering a dynamic work environment in the heart of Oxford, UK, where innovation meets purpose. With a strong commitment to employee growth, we provide comprehensive training and development opportunities alongside competitive benefits such as generous pension contributions, private healthcare, and performance bonuses. Join us to be part of a collaborative culture that values your contributions and empowers you to make a meaningful impact in the field of genomics and diagnostics.
Contact Details:
Oxford Nanopore Technologies Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer - Computer Systems Validation in Oxford
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend meetups, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their values and how your skills align with their mission. This will help you stand out and show that you're genuinely interested in joining the team.
✨Tip Number 3
Practice common interview questions and scenarios related to Quality Engineering and CSV. Mock interviews with friends or mentors can help you refine your answers and boost your confidence.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're keen on being part of our innovative team at Oxford Nanopore Technologies.
We think you need these skills to ace Quality Engineer - Computer Systems Validation in Oxford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Quality Engineer role. Highlight your experience with GxP environments and any relevant certifications to catch our eye!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about CSV and how your background makes you a perfect fit for our team at Oxford Nanopore Technologies.
Showcase Your Technical Writing Skills:Since exceptional technical writing is key for this role, include examples of your documentation work. This could be validation protocols or any other relevant documents you've created in the past.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role without any hiccups!
How to prepare for a job interview at Oxford Nanopore Technologies
✨Know Your GxP Standards
Make sure you brush up on GxP regulations, especially GAMP 5 and 21 CFR Part 11. Being able to discuss these standards confidently will show that you understand the importance of compliance in a Quality Engineer role.
✨Showcase Your Technical Writing Skills
Prepare examples of your technical writing from previous roles. Since this position requires exceptional attention to detail, having concrete examples ready will demonstrate your capability in producing clear and precise documentation.
✨Prepare for Scenario-Based Questions
Expect questions about how you would handle specific validation scenarios or compliance issues. Think through past experiences where you successfully navigated challenges in CSV and be ready to share those stories.
✨Highlight Cross-Functional Collaboration
This role involves working with various teams like IT and R&D. Be prepared to discuss how you've effectively collaborated with different departments in the past, showcasing your ability to influence positive change in a team setting.
