Lead validation activities for the Dotmatics Luma platform and its internal systems operating under GxP requirements
Serve as the subject matter expert for computer system validation (CSV)
Ensure that software development, testing, and release activities comply with applicable regulations and standards
Partner closely with Product, Engineering, and Quality Management teams to drive validation best practices throughout the software development lifecycle (SDLC)
Author, review, and approve validation lifecycle documentation including Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ, OQ, PQ protocols and reports
Working with the software quality team and devops to leverage automated tools such as Cypress to develop, review and run IQ, OQ, and PQ protocols.
Mentor/lead junior validation team members and QA staff on validation methodologies and documentation best practices.
Provide validation guidance and training to engineers, QA analysts, and project managers on CSV principles, IQ/OQ/PQ expectations, and 21 CFR Part 11 controls.

Deep working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements as they apply to software systems
Familiarity with ISO 9001 quality management system principles
Demonstrated experience authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports, including use of automated testing tools (e.g., Cypress, Playwright) to generate and capture test evidence
Understanding of software development lifecycle (SDLC) and Agile methodologies.
Experience with validation of 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 required).
Background in regulated life sciences environments, such as pharmaceutical, biotech, or medical device industries.

Lead Validation Engineer

Key skills