Computer Systems Validation (CSV) Engineer

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 methodology to scope effort proportionate to system risk and complexity. Cross-Functional Collaboration Collaborate with IT, QA, Product Development, Operations, and R&D stakeholders to gather requirements, support implementation, and ensure validation readiness. Translate operational, laboratory, and manufacturing needs into validation strategy and deliverables. Partner with IT Directors (and future CSV Manager and Principal CSV Engineer) to align local execution with the validation framework and programme priorities. Technical Leadership & Mentoring Mentor junior CSV team members and provide technical guidance on CSV best practices. Contribute to internal CSV capability uplift through knowledge sharing and review feedback. Support recruitment and onboarding activities for new CSV team members as requested. Technical Operations & Validation Risk-Based Validation Perform risk assessments using approved methodology and apply a risk-based approach to all CSV activities. Document risk decisions and validation rationale to provide defensible audit evidence. Apply risk-based testing strategies across IQ, OQ, and PQ activities. Change Control & Periodic Review Manage and document change controls for validated systems, ensuring all changes are assessed, approved, and implemented in line with regulatory and Quality Management System (QMS) requirements. Conduct periodic reviews of validated systems to confirm continued compliance and fitness for purpose. Update validation documentation following approved changes to assigned systems. Incident Response & Deviation Management Lead CSV response activities during system incidents or unplanned changes affecting validated environments. Identify, document, and manage deviations, CAPAs, and change controls related to validated systems. Coordinate remediation actions with IT, QA, and business stakeholders, and communicate status throughout. Cloud-Based System Validation Validate and monitor cloud-based GxP applications in line with regulatory expectations. Review cloud system configurations and access controls regularly to maintain a validated state. Partner with IT on cloud infrastructure changes that may impact validated environments. SOPs & Validation Documentation <span style="font-family: helvetica, ar