Validation & Verification Engineer

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.