CSV Engineer

The 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.

• 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.

• 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
• Experience supporting internal and external regulatory audits and inspections as a CSV subject matter expert
• Experience authoring and reviewing CSV SOPs, work instructions, and validation templates
• Strong interpersonal skills and an ability to work as an effective member of a team
• Proven ability to mentor and guide junior engineers, ensuring best practices and effective collaboration.