Lead Verification and Validation Engineer

Summary: The Lead Verification & Validation Engineer will oversee the design outputs and ensure compliance with medical device and pharmaceutical standards during the transition to manufacturing. This role involves leading design reviews, verification testing, and maintaining regulatory documentation while fostering collaboration across departments. The position is based in London with a flexible working model and requires immediate availability.

Key Responsibilities:

• Oversight of completion of design outputs, including technical drawings and product specifications.
• Lead design reviews and verification testing for the device and associated labelling and packaging.
• Coordinate the supply of raw materials for manufacturing DV samples.
• Ensure test methods are documented, validated, and staff are trained.
• Develop design verification protocols and coordinate internal and external testing.
• Analyse test data and prepare design verification reports.
• Lead design validation, including clinical trials and liaise with CROs for documentation.
• Maintain design history files and manage product change control in accordance with relevant procedures.
• Collate the Technical File in accordance with UK, EU, and/or US regulations.

Key Skills:

• Experience in verification and validation processes for combination devices or pharmaceutical products.
• Strong understanding of medical device and pharmaceutical labelling standards and regulations.
• Proficiency in developing design verification protocols and conducting design reviews.
• Ability to coordinate testing and manage documentation for clinical trials.
• Knowledge of regulatory requirements, including 21 CFR part 820.
• Excellent analytical skills for test data analysis and report preparation.
• Strong communication and collaboration skills to work with various departments.

Salary (Rate): £62.50

City: London

Country: United Kingdom

Working Arrangements: hybrid

IR35 Status: outside IR35

Seniority Level: Mid-Level

Industry: Other