Computer Systems Validation Engineer

BridgeView; Colorado; On-site; USD 110,000 - 160,000; Full time

Job summary

BridgeView seeks a CSV Engineer to lead end-to-end validation of computerized systems in a regulated environment in Colorado, USA. You will design, create, and execute validation protocols, test scripts, change management, and end-user training to ensure compliance with ISO 13485 and 21 CFR Part 11.

The role requires authoring and reviewing CSV SOPs, supporting internal and external audits, mentoring junior engineers, and maintaining data integrity across cloud-based GxP applications.

Qualifications

• Experience leading CSV validation efforts in regulated environments.
• Proven ability to author and review validation documentation (URS/FS/DS/VMP/IQ/OQ/PQ).
• Strong knowledge of ISO 13485, 21 CFR Part 11 and data integrity principles.
• Experience supporting internal and external regulatory audits and inspections.
• Ability to mentor junior engineers and promote best practices.

Responsibilities

• Lead planning, authoring, execution, and review of CSV documentation (URS, FRS, DS, VMP, IQ, OQ, PQ).
• Compile validation summary reports and obtain approvals for operational use.
• Ensure compliance with ISO 13485, 21 CFR Part 11, and data integrity principles.
• Perform risk assessments and apply risk-based approaches to CSV activities.
• Lead CSV response during system incidents or changes affecting validated environments.
• Validate and monitor cloud-based GxP applications per regulatory expectations.
• Author and review CSV SOPs and templates.
• Act as CSV SME during audits and inspections.

Skills

CSV leadership

Regulatory compliance

Documentation

Risk assessment

Audits

Team mentoring

Job description

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.

Skills and Requirements

• 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.

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 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.