Lead Validation Engineer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Create, review, and authorize validation lifecycle documentation, including Validation Master Plans, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Traceability Matrices, Risk Assessments, and protocols and reports for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with GAMP 5 principles, employing risk-based validation approaches.

• Collaborate with the software quality team and DevOps to utilize automated tools such as Cypress for the development, review, and execution of IQ, OQ, and PQ protocols.

• Implement the GAMP 5 framework to identify suitable validation strategies and necessary documentation requirements.

• Guide and mentor junior validation team members and QA personnel on validation methodologies and best practices for documentation.

• Organize and carry out validation testing activities, overseeing defect identification, impact assessment, and resolution processes.

• Act as the subject matter expert for Luma on GAMP 5, 21 CFR Part 11, EU Annex 11, and relevant ISO standards.

• Offer validation guidance and training to engineers, QA analysts, and project managers regarding CSV principles, IQ/OQ/PQ expectations, and 21 CFR Part 11 controls.

⛳️ Requirements

• Extensive knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements in relation to software systems.

• Understanding of ISO 9001 quality management system principles.

• Proven experience in authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports, including utilizing automated testing tools such as Cypress and Playwright to generate and capture test evidence.

• Comprehension of the software development lifecycle (SDLC) and Agile methodologies.

• Experience in validating cloud-based systems, SaaS applications, or commercial off-the-shelf (COTS) software.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Flexible work arrangements to support work-life balance.