Quality Engineer

Job Description: The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on

Cornelis Networks delivers the world's highest performance scale-out networking solutions for AI and HPC datacenters. Our differentiated architecture seamlessly integrates hardware, software and system level technologies to maximize the efficiency of GPU, CPU and accelerator-based compute clusters at any scale. Our solutions drive breakthroughs in AI & HPC workloads, empowering our customers to push the boundaries of innovation. Backed by top-tier venture capital and strategic investors, we are

JOB DESCRIPTION: We are seeking a Senior Software Validation & Quality Engineer with experience in regulated environments, preferably medical devices. The ideal candidate will support software quality, validation, testing, compliance, and audit readiness. Key Responsibilities: Review software requirements, design documents, test plans, validation protocols, and reports.Support software V&V, functional/integration/system testing, and validation activities.Maintain requirements traceability (RTM)

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument s