Quality Engineer Computer Systems Validation

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 environmentsensuring 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 Were Looking For

Education & Experience:

• . 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 persons 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.

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