CSV Engineer

Position SummaryThe CSV Engineer 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.Skills and RequirementsLead 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 SOPsPerform 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.Required 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 typesStrong working knowledge of ISO 13485, 21 CFR Part 11, data integrity principlesDemonstrated ability to manage the full CSV lifecycle for multiple systems simultaneouslyExperience supporting internal and external regulatory audits and inspections as a CSV subject matter expertExperience authoring and reviewing CSV SOPs, work instructions, and validation templatesStrong interpersonal skills and an ability to work as an effective member of a teamProven ability to mentor and guide junior engineers, ensuring best practices and effective collaboration.