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Lead Verification and Validation Engineer

RBW Consulting
London
5 months ago
Applications closed

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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 ofdesign outputs, including technical drawings, product and component specifications
  • Oversight of the completion oflabelling and packagingdesign in alignment with the relevant medical device and pharma labelling standards and regulations
  • To lead thedesign reviewsfor the device, ensuring the product design is evaluated against requirements detailed within the TRS and URS
  • To lead thedesign verificationtesting 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 thedesign validationof 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 thedesign history filein accordance with 21 CFR part 820 requirements
  • Manage productchange control, in accordance with the relevant CLCC procedures
  • Maintain theDevice Master Recordin accordance with 21 CFR part 820 requirements


Regulatory

  • Collate theTechnical Filein 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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