CSV Engineer

BridgeView; Colorado; On-site; USD 120,000 - 170,000; Full time

Job summary

BridgeView in the United States (Colorado) seeks a seasoned CSV Engineer to lead validation activities for computerized systems. You will design, execute, and review validation protocols, change controls, and training, ensuring compliance with ISO 13485, 21 CFR Part 11, and data integrity standards. You will mentor junior engineers and support regulatory audits with robust documentation.

Qualifications

• 5+ years in CSV within a regulated environment (biotech, pharma, or medical devices).
• Experience authoring and executing IQ/OQ/PQ protocols for various system types.
• Strong knowledge of ISO 13485 and 21 CFR Part 11, data integrity basics.
• Ability to manage multiple CSV lifecycles simultaneously.
• Experience supporting audits and inspections as a CSV SME.
• Experience authoring CSV SOPs and validation templates.
• Collaborative and able to mentor junior engineers.

Responsibilities

• Lead planning, authoring, execution, and review of CSV documentation.
• Compile validation summary reports and secure approvals for in-use systems.
• Ensure compliance with ISO 13485, 21 CFR Part 11, and data integrity.
• Perform risk assessments and apply risk-based approaches to CSV work.
• Lead CSV response during incidents or changes in validated environments.
• Validate and monitor cloud-based GxP applications per regulatory expectations.
• Author/review CSV SOPs, work instructions, and templates.
• Serve as CSV SME during internal audits and regulatory inspections.

Skills

CSV leadership

Regulatory compliance

Risk assessment

Audits & inspections

SOP development

Team mentorship

Documentation

GxP knowledge

Tools

IQ/OQ/PQ protocols

URS/FRS/DS docs

VMP

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.