Computer Systems Validation (CSV) Engineer
Watchmakergenomics · Boulder, CO
About this role
**Computer Systems Validation (CSV) Engineer** **Position Type:** Full-time, permanent **Department:** Information Technology (IT) **Location:** Boulder, onsite **Experience / Education** Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related discipline **and 5+ years** CSV experience in a **GxP-regulated** environment. Will consider candidates without a Bachelor’s degree with commensurate experience (**AS + 7 years** or **no degree + 9 years**). --- ## Position Summary Watchmaker Genomics is seeking a **Computer Systems Validation (CSV) Engineer** for an **on-site** role in **Boulder, Colorado**, reporting to the **Director of IT**. You will lead the **end-to-end validation** of computerized systems in a regulated environment, including day-to-day work such as **validation protocol/test execution**, **change management**, and **end-user training**. You will also help create and maintain CSV-related documentation and processes aligned to **ISO 13485:2016**, **GxP**, and **21 CFR Part 11** (e.g., plans, URS documentation, assessments, and summary reports). --- ## Responsibilities ### Core Responsibilities - Lead planning, authoring, execution, and review of CSV documentation, including **URS, FRS, DS, VMP, IQ, OQ, and PQ** protocols. - Manage the full lifecycle of assigned systems (laboratory, manufacturing, and cloud-based applications). - Compile validation summary reports and secure required approvals for systems entering operational use. - Apply **risk-based validation** to scope effort proportional to system risk and complexity. ### Cross-Functional Collaboration - Collaborate with **IT, QA, Product Development, Operations, and R&D** to gather requirements, support implementation, and ensure validation readiness. - Translate operational, laboratory, and manufacturing needs into validation strategy and deliverables. - Partner with IT leadership (and future CSV Manager/Principal CSV Engineer) to align local execution with the validation framework and program priorities. ### Technical Leadership & Mentoring - Mentor junior CSV team members and provide technical guidance on CSV best practices. - Support CSV capability uplift through knowledge sharing and review feedback. - Assist with recruitment and onboarding for new CSV team members as needed. ### Technical Operations & Validation - Perform risk assessments using approved methodology and apply risk-based approaches across CSV activities. - Document risk decisions and validation rationale for defensible audit evidence. - Apply risk-based testing strategies across **IQ, OQ, and PQ**. ### Change Control & Periodic Review - Manage and document change controls for validated systems, ensuring changes are assessed, approved, and implemented per regulatory and QMS requirements. - Conduct periodic reviews to confirm continued compliance and fitness for purpose. - Update validation documentation following approved changes. ### 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 with IT, QA, and business stakeholders; communicate status throughout. ### Cloud-Based System Validation - Validate and monitor cloud-based **GxP** applications in line with regulatory expectations. - Review cloud configurations and access controls re
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