watchmakergenomics · Boulder, CO
Position: Computer Systems Validation (CSV) Engineer Position Type: Full-time, permanent Department: Information Technology (IT) Location: Boulder, onsite Experience: Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related discipline and 5+ years CSV experience in a GxP-regulated environment. Will consider those without a Bachelors with commensurate experience (AS+7 years or no degree+9 years). Position Summary Watchmaker Genomics is inviting applications for the full-time Computer Systems Validation (CSV) Engineer position, an on-site role in Boulder, Colorado. This position reports to the Director of IT, Boulder, and is responsible for leading the end-to-end validation of computerized systems within the environment. This position will perform day-to-day tasks related to the design, creation, and execution of validation protocols, test scripts, change management, and end-user training activities. Additionally, this position is expected to assist in creating new processes, ISO 13485:2016, GxP, and 21 CFR Part 11-related documentation to support and maintain the organization's computer systems validation efforts. This may include, but not be limited to, plans, URS documentation, assessments, and summary reports. The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and compliance posture. This position will offer unique challenges, learning, and growth in a cutting-edge genomics and life sciences environment. Responsibilities Core Responsibilities Validation Lifecycle & Delivery Lead the planning, authoring, execution, and review of computer systems validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols. Manage the full lifecycle of assigned systems, including laboratory, manufacturing, and cloud-based applications. Compile validation summary reports and secure required approvals for systems entering operational use. Apply risk-based validation …t…
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