Lead Validation Engineer

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Oversee validation processes for the Dotmatics Luma platform and internal systems that operate under GxP standards.

• Act as the subject matter expert in computer system validation (CSV).

• Ensure that software development, testing, and deployment activities adhere to relevant regulations and standards.

• Write, review, and approve documentation for the validation lifecycle, including Validation Master Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices, Risk Assessments, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.

• Collaborate with software quality and DevOps teams to utilize automated tools like Cypress for IQ, OQ, and PQ protocols.

• Implement GAMP 5 guidelines to define validation strategies and documentation needs.

• Mentor and guide junior validation team members and QA personnel.

• Offer validation support and training to engineers, QA analysts, and project managers.

• Assist with customer-focused validation activities.

• Manage validation testing and defect resolution processes.

• Contribute to CAPA investigations and responses to audits.

• Partner with Quality Management to ensure document control, conduct periodic reviews, and maintain audit preparedness.

⛳️ 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.

• Proficiency in utilizing automated testing tools such as Cypress or Playwright to generate and capture testing evidence.

• Familiarity with the software development lifecycle (SDLC) and Agile methodologies.

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

• Bachelor’s degree in Computer Science, Biology, Chemistry, Engineering, or a related field (preferred but not mandatory).

• Background in regulated life sciences sectors, including pharmaceutical, biotech, or medical device industries.

🏝️ Benefits

• A dynamic, remote-friendly workplace.

• A collaborative global team environment.

• An equal opportunity employer.

• A supportive and connected work culture.