GxP Validation Architect - FDA Part 11 Expert

AnovoRx Holdings LLC; Memphis, Northern (TN, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

AnovoRx Holdings LLC in Memphis, TN seeks a Technical Validation Architect to own CSV strategy ensuring FDA 21 CFR Part 11 compliance for electronic records, signatures, and audit trails. The role bridges software engineering, QA, and regulatory affairs to translate requirements into architecture, pipelines, and controls.

Responsibilities include developing the CSV master plan, executing IQ/OQ/PQ protocols, collaborating with the Enterprise Architect and engineering to embed validation in CI/CD,

Qualifications

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
• 7+ years of experience in computer system validation (CSV) within FDA-regulated environments (pharma, biotech, or medical device).
• Deep working knowledge of 21 CFR Part 11 (electronic records/signatures) and data integrity principles (ALCOA+).
• Hands-on experience authoring and executing IQ/OQ/PQ protocols and validation summary reports.
• Familiarity with GAMP 5 risk-based validation methodology.
• Understanding of modern SDLC and CI/CD practices (Git-based workflows, automated deployment pipelines) and how to apply validation controls without blocking agile delivery.
• Strong technical writing and documentation skills.
• Experience supporting FDA inspections or client audits.

Responsibilities

• Develop and maintain the CSV master plan and validation strategy for the Aperture platform.
• Assess Aperture's architecture against 21 CFR Part 11 requirements for electronic records, audit trails, and electronic signatures.
• Author and execute IQ, OQ, and PQ protocols.
• Partner with the Enterprise Architect and engineering teams to embed validation and compliance-by-design controls into the CI/CD pipeline.
• Define audit trail, data integrity (ALCOA+), and electronic signature requirements, and validate their implementation.
• Lead risk assessments using a GAMP 5 risk-based approach to determine validation scope and rigor for platform components and changes.
• Build and maintain a change control process for Aperture that satisfies Part 11 while supporting agile, continuous delivery.
• Prepare and maintain validation documentation: URS, FRS, DDS, traceability matrices, and validation summary reports.
• Serve as the technical subject matter expert during internal audits, client due-diligence reviews, and FDA inspections involving Aperture.
• Train engineering and product teams on validation requirements and data integrity principles.
• Coordinate with Quality Assurance and Regulatory Affairs to align IT validation practices with Anovo's broader GxP compliance program.

Skills

CSV validation

21 CFR Part 11

IQ/OQ/PQ protocols

GAMP 5 risk-based validation

SDLC & CI/CD

Regulatory audits support

Technical writing

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

Tools

AWS

Kubernetes

Git-based workflows

Argo CD

PostgreSQL

Core .NET

React

Job description

AnovoRx Holdings LLC in Memphis, TN seeks a Technical Validation Architect to own CSV strategy ensuring FDA 21 CFR Part 11 compliance for electronic records, signatures, and audit trails. The role bridges software engineering, QA, and regulatory affairs to translate requirements into architecture, pipelines, and controls.

Responsibilities include developing the CSV master plan, executing IQ/OQ/PQ protocols, collaborating with the Enterprise Architect and engineering to embed validation in CI/CD,