Lead Validation Engineer

Job not on LinkedIn

🔥 3 minutes ago

🌐 Ireland, United Kingdom – Remote

🇮🇪 Ireland – Remote 🇬🇧 United Kingdom – Remote

💵 £69.1k - £93.4k / year

⏰ Full Time

🟠 Senior

👷🏻‍♀️ Engineer

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Dotmatics

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Dotmatics is an AI-powered scientific intelligence platform that specializes in data management and workflow automation specifically for multimodal scientific discovery. It facilitates adaptive lab workflows, enhances collaboration across various scientific disciplines, and integrates advanced predictive analytics to accelerate research and development. With a suite of products, including solutions for bioinformatics, cheminformatics, and flow cytometry, Dotmatics supports researchers in making informed decisions, streamlining operations, and driving innovation in drug discovery and materials science.

📋 Description

• Lead validation activities for the Dotmatics Luma platform and internal systems operating under GxP requirements • Serve as subject matter expert for computer system validation (CSV) • Ensure software development, testing, and release activities comply with applicable regulations and standards • Author, review, and approve validation lifecycle documentation, including Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ, OQ, and PQ protocols and reports • Work with software quality and DevOps teams to leverage automated tools such as Cypress for validation protocols • Apply GAMP 5 to determine validation strategies and documentation requirements • Mentor and lead junior validation team members and QA staff • Provide validation guidance and training to engineers, QA analysts, and project managers • Support customer-facing validation activities, validation testing, defect resolution, CAPA investigations, and audit responses • Collaborate with Quality Management to maintain document control, periodic reviews, and audit readiness

🎯 Requirements

• 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 • Experience using automated testing tools such as Cypress or 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

🏖️ Benefits

• Remote-friendly environment • Equal opportunity workplace • Welcoming and supportive work environment • Collaborative global team • Tangible impact on scientific innovation