Shape the Future of Medicine: Engineering Validation Specialist - London

Join a pioneering biotech company at the forefront of developing life-changing gene therapies!

Our client, a clinical-stage leader with a global footprint, is seeking a talented and experienced Engineering Validation Specialist to strengthen their team in London. This is a permanent, full-time opportunity to play a vital role in ensuring the integrity and compliance of their cutting-edge operations.

Your Mission:

As an Engineering Validation Specialist, you'll be a key player in supporting all GxP validation requirements across processes, equipment, facilities, and computerised systems. You'll be the go-to SME for EU and FDA regulations, driving compliance and best practices. This role involves a comprehensive review of validation documentation, supporting QMS activities (deviations, change controls), and collaborating cross-functionally with diverse departments, including QA, IT, and Manufacturing. You'll also have the opportunity to represent the company as a Validation compliance expert during regulatory inspections.

We're looking for someone with:

• A degree in Biomedical Engineering, Sciences, or a related field with commercial experience.
• A minimum of 5 years' experience predominantly in Engineering Validation, with a strong focus on Computer System Validation (CSV).
• Deep practical knowledge of GxP regulations and guidelines for validation and qualification.
• Exceptional communication skills, an approachable professional manner, and a proactive approach to problem-solving in a dynamic environment.

This is a chance to contribute to a company with a state-of-the-art manufacturing facility and a commitment to innovation in gene therapy.

Ready to make a difference?

Apply now!