Lead Validation Engineer | Luma

Role overview Lead computer system validation for a scientific software platform and related internal systems subject to GxP requirements. You will set risk-based validation approaches across the software development lifecycle, partnering with product, engineering, quality, and DevOps teams to keep releases traceable, compliant, and audit-ready.

Responsibilities - Author, review, and approve validation plans and records, including requirements, risk assessments, traceability matrices, and IQ/OQ/PQ protocols and reports. - Apply GAMP 5 principles to define validation scope, evidence, and documentation for software changes and releases. - Work with software quality and DevOps teams to use automated testing tools to develop and execute validation protocols and capture evidence. - Advise and train engineers, QA analysts, and project managers on computer system validation, testing expectations, and electronic-record controls. - Mentor junior validation and QA colleagues on methods and documentation practices. - Support customer validation work, test coordination, defect resolution, CAPA investigations, audit responses, document control, and periodic reviews.

Requirements - Strong working knowledge of GAMP 5, GxP, 21 CFR Part 11, and EU Annex 11 as applied to software systems. - Experience creating and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports. - Familiarity with automated testing tools such as Cypress or Playwright and using them to capture test evidence. - Understanding of software development lifecycles and Agile ways of working. - Experience validating cloud systems, SaaS products, or commercial off-the-shelf software. - Familiarity with ISO 9001 quality management principles.

Nice to have - A degree in computer science, life sciences, engineering, or a related discipline. - Experience in a regulated pharmaceutical, biotechnology, or medical device setting.