Validation & Verification Engineer
Location | Greater London |
Job type: | Contract |
Contact name: | Jamie Fisher |
Contact email: | jamie.fisher@rbwconsulting.com |
Contact phone: | +44 1293 584 300 |
Job ref: | JFVVENG |
Published: | about 9 hours ago |
Expiry date: | 09 Jun 2025 23:59 |
Startdate: | ASAP |
Design Verification & Validation Engineer | 12 month contract | £350-500 per day | Outside IR35 | London | Immediate start
One of my long-standing clients is looking for a V&V engineer as they transfer into manufacturing, ideally with a background in combination devices/pharmaceutical products.
They're based in London, but have a flexible working model. You'll be working closely with various heads of department to engender a collaborative and productive working environment.
They're true innovators into a critical area of unmet need, with a genuinely ground-breaking product.
Job overview:
Oversight of completion of
design outputs, including technical drawings, product and component specifications
Oversight of the completion of
labelling and packaging
design in alignment with the relevant medical device and pharma labelling standards and regulations
To lead the
design reviews
for the device, ensuring the product design is evaluated against requirements detailed within the TRS and URS
To lead the
design verification
testing of the device and associated labelling and packaging.
Coordinate the supply of raw materials for the manufacture of DV samples
Ensure test methods are documented, validated and staff are trained (training is recorded)
Develop the design verification protocol, including traceability to the TRS and test reports
Coordinate internal and external testing in accordance with the protocol
Analyse test data and prepare a design verification report
To lead the
design validation
of the device, including Clinical trials
As above for design verification, plus:
Liaison with the CRO, including the coordination of all documentation and evidence required for the clinical trial
Maintain the
design history file
in accordance with 21 CFR part 820 requirements
Manage product
change control, in accordance with the relevant CLCC procedures
Maintain the
Device Master Record
in accordance with 21 CFR part 820 requirements
Regulatory
Collate the
Technical File
in accordance with the relevant regulations (could be UK, EU and / or US)
Please apply right away to be considered for this great opportunity.
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