At a Glance
- Tasks: Ensure compliance and validation of cutting-edge computer systems in a dynamic biotech environment.
- Company: Join Oxford Nanopore Technologies, a leader in innovative genomics solutions.
- Benefits: Enjoy competitive salary, bonuses, private healthcare, and generous pension contributions.
- Other info: Collaborative culture with opportunities for personal and professional growth.
- Why this job: Make a real impact on global health by supporting transformative technologies.
- Qualifications: Degree in Computer Science or related field; experience in GxP environments preferred.
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.
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.
Quality Engineer - Computer Systems Validation in Oxford employer: Oxford Nanopore
At Oxford Nanopore Technologies, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the biotech sector. Our hybrid working model in Oxford allows for flexibility while providing access to outstanding benefits, including a competitive salary, generous pension contributions, and private healthcare. Join us to contribute to groundbreaking advancements in genomics and diagnostics, with ample opportunities for professional growth and development.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer - Computer Systems Validation in Oxford
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Oxford Nanopore. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Oxford Nanopore!
We think you need these skills to ace Quality Engineer - Computer Systems Validation in Oxford
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Oxford Nanopore that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Oxford Nanopore.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Oxford Nanopore does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Oxford Nanopore
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Oxford Nanopore. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Oxford Nanopore's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Oxford Nanopore. This shows your passion for the industry!
