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
What Were Looking For
Education & Experience:
Knowledge Skills & Attributes:
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.
#LI-JC1
Required Experience:
IC
Quality Engineer Computer Systems Validation • Oxford, England, UK
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