Quality Engineer - Computer Systems Validation
£36.8 - £42.6 per hourEstimated
Full-time
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
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.
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.
- 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 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.
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.
Vacancy posted 11 days ago
Similar jobs that could be interesting for youBased on the Quality Engineer - Computer Systems Validation in Oxford, Oxfordshire vacancy
- £45k - £58k per annumEstimated...-latency connectivity. Our systems are at the forefront of innovation... ...for a talented Systems Engineer to support the cloud software... ...testing and initial operations to validate system functionality and ensure... ..., Software Engineering, Computer Science, or a related field....ComputerFull-timeFlexible hours
- £39k - £51k per annumEstimated...than 160 countries and regions. Position Summary The Quality Engineer, Validation is responsible for ensuring that manufacturing processes... ...recognised guidance for process validation and measurement system analysis, ensuring outputs support design transfer and meet...Suggested
- £37k - £47k per annumEstimated...regions. Position Summary The Software Quality Engineer is responsible for supporting software... ...test reports for OrganOx devices and systems, according to OrganOx documentation procedures... ...~ A degree in software engineering, computer science, information engineering or...ComputerOn-siteFlexible hours
£28k - £30k per annum
...environments. They are looking to hire a Graduate / Junior QA Engineer to join their growing Quality Assurance team. This is an excellent opportunity for... ...in a subject such as Physics, Mathematics, Engineering, Computer Science, Natural Sciences or similar Excellent...ComputerLong-term contractPart-timeSummer workInternshipPlacement yearSummer internshipHybrid workingOn-site- £39k - £53k per annumEstimated...Power Systems Engineer - London, Bicester or Newcastle RED are an expanding international M... ...primary responsibilities will include running computer simulations, working with design teams,... ...3. Documentation and Reporting: Validate input data to ensure accuracy and reliability...ComputerHybrid working
- £62k - £82k per annumEstimated...the next generation of quantum computing. Using our world-leading... ...accurate and reliable quantum systems to tackle problems that today... ...science teams to deliver first engineering units. You will drive engineering... ...systems needed to develop, validate, and operate our products....ComputerFull-timeHybrid workingFlexible hours
- £43k - £55k per annumEstimated...statistical inference, and data engineering could directly shape how the world's most advanced AI systems reason and solve problems? We'... ...a passion for rigorous, high-quality technical work.... ...optimization, Bayesian inference, cross-validation strategies, dimensionality reduction...ComputerHourly payOngoing contractFreelanceRemoteFlexible hours
£25.27k per annum
...routine problems which may prevent adherence to decontamination/quality standards. Specific hand/eye co-ordination required to gain the... ...untrained staff when qualified. Responsible for data entry onto computer, to maintain records of instrumentation within the department (tracking...ComputerFull-time- £63k - £81k per annumEstimated...Product Lead, Manufacturing Execution System (MES) Oxford Nanopore The Role... ...strategy, enabling manufacturing process engineers to safely and consistently self configure... ...across Production and Tech Transfer, and Quality, Validation, and Regulatory stakeholders. Key...ComputerFull-timeHybrid working
£28 - £32 per hour
...current Support routine office-related processes through accurate and consistent task completion Requirements Reliable computer or laptop Stable internet connection Ability to follow written instructions carefully Comfort using email, web browsers,...ComputerRemote jobHourly payFull-timePart-timeOn-siteWork from homeHRS Talent Solutions
Oxford, Oxfordshire11 days ago- £33k - £42k per annumEstimated...technology which integrates robotics, computer vision, and data... ...implement automated robotic systems for transformation and tissue... ...the transformation pipeline, validation of phenotyping and automation... ...Partner with AIR and data engineering teams to establish robust data...ComputerLong-term contract
£45k - £55k per annum
...This is an exciting opportunity to work at the intersection of Computer Vision, AI/Deep Learning, and Medical Physics, developing innovative... ...As an Imaging Scientist II, you will research, develop, and validate advanced computational imaging solutions, supporting both internal...ComputerLong-term contractPermanentFlexible hours- £74k - £95k per annumEstimated...the next generation of quantum computing. Using our world-leading... ...accurate and reliable quantum systems to tackle problems that today... ...are looking for a Staff FPGA Engineer to join our FPGA Team at IonQ... ...automated firmware build and validation Experience working closely...ComputerFull-timeHybrid workingFlexible hours
- £53k - £70k per annumEstimated...the next generation of quantum computing. Using our world-leading... ...accurate and reliable quantum systems to tackle problems that today... ...They are responsible for validating and optimising the performance... ...class community of scientists, engineers and innovators working to unlock...ComputerFull-timeHybrid workingFlexible hours
$35 - $60 per hour
...Computer Engineering - AI Data Trainer ~ Location: Remote About The Job At Alignerr, we... ...architecture and hardware design, embedded systems and IoT, networking and distributed... ...experience with data annotation, data quality, or evaluation systems Proficiency in...ComputerHourly payFreelanceRemoteFlexible hours- £28k - £36k per annumEstimated...mathematical proofs into Lean 4 (and related proof systems) with an emphasis on clarity, structure,... ...in Mathematics, Logic, Theoretical Computer Science, or a closely related field... ...Prior experience with data annotation, data quality, or evaluation systems Familiarity with...ComputerHourly payOngoing contractFreelanceRemoteFlexible hours
- £31k - £41k per annumEstimated...elegance, and the challenge of pushing formal systems to their limits. Organization:... ...higher in Mathematics, Logic, Theoretical Computer Science, or a closely related field Strong... ...experience with data annotation, data quality, or AI evaluation workflows Strong written...ComputerHourly payOngoing contractFreelanceRemoteFlexible hours
£45k - £55k per annum
...Quality Engineer - Civil Engineering (Didcot) - Drive Quality on Major Infrastructure Projects Are you a detail-focused Quality Engineer... ...will be: ·Implementing and maintaining the QA/QC management system on site ·Coordinating inspections with subcontractors and vendors...PermanentFull-time£17.13k per annum
...apply, you must be able to evidence your NI number and right to work in the UK, ideally have photographic ID (valid passport or driving licence), have access to a computer, been resident in the UK for at least 3 years and be comfortable travelling to the training sessions in...ComputerHourly payPermanentApprenticeshipMonday to FridayShift work- £78k - £103k per annumEstimated...the next generation of quantum computing. Using our world-leading... ...accurate and reliable quantum systems to tackle problems that today... ...closely with IonQ’s Product, Engineering, Field Engineering and Customer... ...buying process involves technical validation, long-term strategic planning...ComputerLong-term contractHybrid workingFlexible hours
- £46k - £62k per annumEstimated...commitment to delivering high-quality, timely services across a... ...model development, testing, validation, benchmarking, and training data... ...machine learning, and software engineering technologies, and proactively... ...experience in AI/ML/NN/computer vision solution development...ComputerFull-time
- £51k - £67k per annumEstimated...build and integrate quantum computers, sensors, and networks. From... ...a Mixed Signals Electronics Engineer . LOCATION Infleqtion... ...implementation of electronic systems and subsystems for Infleqtion... ...execute testing protocols to validate design performance against specifications...ComputerFull-timeOn-siteWork from homeFlexible hours
- £41k - £53k per annumEstimated...company with global operations and customers in more than 125 countries. We are looking for a highly motivated individual to join our engineering team as a Production Compliance Engineer to Engineer to support compliance activities of new product releases and managing current...Full-time
£28k - £30k per annum
...scanners for the picking of items. Picking of items for the engineering team Breaking down of palletised goods Stock... ...Counterbalance Forklift licence. Knowledge of using in-house warehouse computer systems and hand held scanners would be advantageous. Some lifting...ComputerPermanentMonday to Friday- ...Computer Science Teacher – Experienced and ECT Teachers The School is looking for a Computer Science Teacher to work in an Good School starting in September on a full time basis. The School is located in Oxford and is looking for someone who can teach Computer Science up...ComputerFull-timeImmediate start
- ...Computer Science Teacher – Experienced and ECT Teachers The school I am recruiting for is looking for a Computer Science Teacher to work in an Outstanding School starting in September on a full-time basis. The School is located in Oxford and is looking for someone who can...ComputerFull-timeImmediate start
- £31k - £40k per annumEstimated...a hands-on and technically adept GxP IT Systems Engineer to support Moderna’s manufacturing operations... ...change execution activities in a validated GxP environment, maintaining audit trails... ..., and asset tracking. Deliver a high-quality, customer-centric experience in all end-...ComputerLong-term contractWork from homeWeekend work
- £47k - £60k per annumEstimated...build and integrate quantum computers, sensors, and networks. From... ...seeks an experienced optical engineer with a background in optical... ...design, build and test optical systems in a diverse and collaborative... ...process for optical systems. ~ Validate and characterise optical...ComputerFull-timeOn-siteWork from home2 days/week
- £57k - £74k per annumEstimated...boundaries of technology by creating systems that don't just assist but... ...seeking a Field Deployment Engineer to join our team and help... ...-lab and in-field to maintain quality standards Documentation:... ...UK and internationally. A valid UK driving licence and the ability...ComputerFull-timeRelocation packageOn-siteRemoteMonday to Friday
- £41k - £54k per annumEstimated...visionary scientists, technologists, engineers, researchers, educators and... ...will generate biological systems that perform the desired functions... ...have access to substantial compute resources that can be leveraged... ..., configure, scale, and validate compute, storage, networking,...ComputerLong-term contractLive-inHybrid workingOn-siteRemoteRelocation
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Engineer - Computer Systems Validation. Be the first to apply!
Related searches
- supplier quality engineer Oxford, Oxfordshire
- quality engineer Oxford, Oxfordshire
- quality systems engineer Oxford, Oxfordshire
- business systems engineer Oxford, Oxfordshire
- advanced system engineer Oxford, Oxfordshire
- senior systems engineer Oxford, Oxfordshire
- systems engineer Oxford, Oxfordshire
- healthcare systems engineer Oxford, Oxfordshire
- requirements systems engineer Oxford, Oxfordshire
- service quality Oxford, Oxfordshire