Quality engineer, validation Work, Jobs in Cowley, Oxf (with Salaries)

Quality Engineer - Computer Systems Validation
Oxford Nanopore Technologies —Oxford
- Full-time
- Computer Science
- Engineering
- Bachelor's degree
3d
(Fixed Term) Laboratory Technician, Clinical Biomarker Laboratory, Immunoassay
Moderna, Inc. —Oxford
- Overtime
- Microsoft Powerpoint
- Laboratory experience
- Master's degree
- Annual leave
Research Assistant for Innate Immunity Lab
University of Oxford —Oxford
- £35,681 a year
- Full-time
1d
(Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory
Moderna, Inc. —Oxford
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Annual leave
Quality Engineer
UK Atomic Energy Authority —Abingdon
- £57,117 a year
- Full-time
- Hybrid work
- Engineering
- Project management
- Annual leave
- Employee assistance programme
Quick apply
8d
Production Technician (Process Chemistry)
FluoRok Limited —Oxford
- £30,000 - £35,000 a year
- Full-time
- Laboratory experience
- Microsoft Office
- Master's degree
- Life insurance
Quick apply
13d
Validation Technician III
Technical Safety Services —Oxford
- £40,000 - £45,000 a year
- Full-time
- Microsoft Word
- Microsoft Outlook
- Microsoft Office
- Annual leave
Data Quality Assistant
NHS Thames Valley Integrated Care Board —Oxford
- £28,392 - £31,157 a year
- Full-time
- SQL
15h
Data Integrity Officer
NHS Thames Valley Integrated Care Board —Oxford
- £32,073 - £39,043 a year
- Full-time
- Nursing home
- Leadership
15h
Supplier Quality Engineer
Prodrive —Banbury
- Full-time
- Travel
- Employee discount
Quick apply
Quality Systems Engineer
Ionetic —Brackley
- Full-time
- Engineering
- Data analysis skills
- Project management
Quick apply
Radiopharmacy Technician Oxford
Curium Pharma —Oxford
- 12 hour shift
- Computer literacy
- Communication skills
Opportunities Across Quality, NDT & Inspection
Aston Martin F1 —Silverstone
- Full-time
- Assembly
- Continuous improvement
- Communication skills
Quick apply
12d
Laboratory Analyst I
Abbott Laboratories —Witney
- Full-time
- Laboratory experience
- Bachelor's degree
- Communication skills
QA Validation & Qualification Documentation Reviewer
Thermo Fisher Scientific —Swindon
- Full-time
- Master's degree
- Bachelor's degree
- Organisational skills
12d
Quality Engineer
EKFB —Aylesbury
- Quality control
- Construction
- Communication skills
Anaesthetic Administration Coordinator
Oxford University Hospitals NHS Foundation Trust —Oxford
- £28,392 - £31,157 a year
- Full-time
2d
(Fixed Term) Senior Research Associate, Clinical Biomarker Laboratory, Flow Cytometry
Moderna, Inc. —Oxford
- Full-time
- Laboratory experience
- Microsoft Office
- Presentation skills
- Annual leave
Senior Analyst
Abbott Laboratories —Abingdon
- Full-time
- Laboratory experience
PROJECT QUALITY ENGINEER - TALENT COMMUNITY
Laing O'Rourke —Aylesbury
- IT
- Construction
- Communication skills

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Quality Engineer - Computer Systems Validation

Oxford Nanopore Technologies -
Oxford

Apply Now

Job details

Permanent | Full-time
3 days ago

Benefits

Company pension
Private medical insurance

Qualifications

GAMP
Computer Science
Engineering
Quality management
ISO 9001
Bachelor's degree
Technical writing
FDA regulations
SDLC

Full job description

Quality Engineer â€“ 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 â€“ 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 environmentsâ€”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.

Apply Now

Refine Your Search

quality engineer, validation jobs in cowley, oxf

Quality Engineer - Computer Systems Validation

(Fixed Term) Laboratory Technician, Clinical Biomarker Laboratory, Immunoassay

Research Assistant for Innate Immunity Lab

(Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory

Quality Engineer

Production Technician (Process Chemistry)

Validation Technician III

Data Quality Assistant

Data Integrity Officer

Supplier Quality Engineer

Quality Systems Engineer

Radiopharmacy Technician Oxford

Opportunities Across Quality, NDT & Inspection

Laboratory Analyst I

QA Validation & Qualification Documentation Reviewer

Quality Engineer

Anaesthetic Administration Coordinator

(Fixed Term) Senior Research Associate, Clinical Biomarker Laboratory, Flow Cytometry

Senior Analyst

PROJECT QUALITY ENGINEER - TALENT COMMUNITY

I want to receive the latest job alerts for quality engineer, validation in cowley, oxf

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