Lead 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.