Lead Validation Engineer | Luma in United Kingdom

Lead Validation Engineer role at Dotmatics overseeing computer system validation for the Luma platform under GxP requirements. Responsible for validation lifecycle documentation, regulatory compliance (21 CFR Part 11, EU Annex 11, GAMP 5), and mentoring validation teams across the software development lifecycle.

Responsibilities

• Author, review, and approve validation master plans and lifecycle documentation following GAMP 5 principles
• Collaborate with software quality and DevOps teams to develop and execute automated IQ, OQ, and PQ protocols
• Serve as subject matter expert on regulatory standards and validation methodologies for stakeholders
• Mentor junior validation team members and provide training on CSV principles and compliance expectations
• Guide product, engineering, and quality teams on validation strategy and best practices throughout SDLC

Requirements

• Expert knowledge of GAMP 5 framework and risk-based validation approaches
• Deep understanding of 21 CFR Part 11, EU Annex 11, ICH Q10, and ISO 9001 standards
• Experience authoring and approving validation documentation (URS, FRS, IQ, OQ, PQ protocols)
• Proficiency with automated testing tools such as Cypress
• Ability to mentor junior validation team members and QA staff
• Computer system validation and SDLC expertise in regulated environments