Hiring: CSV Engineer Company: BridgeView Location: Boulder County, CO Job Posted Time: 2026-09-16 13:29:21 Target Skills & Keywords : Change Management About the job Experience: •Minimum 5 years of experience in CSV within a regulated environment (biotech, pharma, or medical devices) •Proven experience authoring and executing IQ/OQ/PQ protocols for a range of system types •Strong working knowledge of ISO 13485, 21 CFR Part 11, data integrity principles •Demonstrated ability to manage the full CSV lifecycle for multiple systems simultaneously •Strong interpersonal skills and an ability to work as an effective member of a team Required Skills: •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. Qualifications: •Lead the planning, authoring, execution, and review of computer systems validation documentation, including URS, FRS, DS, VMP, IQ, OQ, and PQ protocols. •Compile validation summary reports and secure required approvals for systems entering operational use. •Ensure compliance with ISO 13485, 21 CFR Part 11, data integrity principles, and applicable SOPs •Perform risk assessments using approved methodology and apply a risk-based approach to all CSV activities. •Lead CSV response activities during system incidents or unplanned changes affecting validated environments. •Validate and monitor cloud-based GxP applications in line with regulatory expectations. •Author and review CSV SOPs, work instructions, and standard templates. •Serve as CSV subject matter expert during internal audits and external regulatory inspections for assigned systems. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!