CSV & Part 11 Architect for Regulated Platforms

Anovorx Group LLC; Lauderdale Courts (TN); On-site; USD 120,000 - 180,000; Full time

Job summary

AnovoRx in Memphis, TN seeks a Technical Validation Architect to own CSV strategy and execution for the Aperture platform, ensuring FDA 21 CFR Part 11 compliance. This role blends software engineering, QA, and regulatory compliance to translate ALCOA+ requirements into architecture, pipelines, and controls.

The candidate will develop master plans, author IQ/OQ/PQ, and defend controls in audits and inspections, partnering across IT and QA to align validation with GxP programs.

Qualifications

• Bachelor’s degree in a related field and 7+ years of CSV experience in FDA-regulated environments.
• Deep knowledge of 21 CFR Part 11 and data integrity principles (ALCOA+).
• Hands-on experience with IQ/OQ/PQ and validation documentation.
• Familiarity with GAMP 5 risk-based validation and Agile CI/CD.

Responsibilities

• Develop and maintain CSV master plan and validation strategy for the platform and GxP systems.
• Assess architecture against Part 11 requirements for records, signatures, and audit trails.
• Author IQ/OQ/PQ protocols and validation summary reports.
• Embed validation controls into CI/CD with engineers and architects.
• Lead risk assessments and define audit trail requirements.
• Prepare validation documentation and support audits/inspections.

Skills

CSV expertise

21 CFR Part 11

data integrity ALCOA+

SDLC / CI-CD understanding

technical writing

audit readiness

Education

Bachelor's degree in CS/Engineering/Life Sciences

7+ years CSV in FDA-regulated environments

Tools

AWS

Kubernetes

React

PostgreSQL

Git / CI/CD tools

Argo CD

Microsoft Entra ID

Job description

AnovoRx in Memphis, TN seeks a Technical Validation Architect to own CSV strategy and execution for the Aperture platform, ensuring FDA 21 CFR Part 11 compliance. This role blends software engineering, QA, and regulatory compliance to translate ALCOA+ requirements into architecture, pipelines, and controls.

The candidate will develop master plans, author IQ/OQ/PQ, and defend controls in audits and inspections, partnering across IT and QA to align validation with GxP programs.