Technical Validation Architect

Anovorx Group LLC; Lauderdale Courts (TN); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CSV expertise

21 CFR Part 11

data integrity ALCOA+

SDLC / CI-CD understanding

technical writing

audit readiness

Formazione

Bachelor's degree in CS/Engineering/Life Sciences

7+ years CSV in FDA-regulated environments

Strumenti

AWS

Kubernetes

React

PostgreSQL

Git / CI/CD tools

Argo CD

Microsoft Entra ID

Descrizione del lavoro

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Technical Validation Architect

Full Time Professional Memphis, TN, US

Job Summary:

The Technical Validation Architect owns computer system validation (CSV) strategy and execution for the Aperture platform, ensuring it meets FDA 21 CFR Part 11 requirements for electronic records, electronic signatures, and audit trails. This role sits at the intersection of software engineering, quality assurance, and regulatory compliance — translating Part 11 and data integrity (ALCOA+) requirements into concrete architecture, pipeline, and process controls, and defending those controls in audits and inspections.

The below is intended to describe the general content of and requirements for the performance of this job and is not to be construed as an exhaustive statement of essential functions, responsibilities, or requirements.

Primary Duties and Responsibilities

• Develop and maintain the Computer System Validation (CSV) master plan and validation strategy for the Aperture platform and other GxP-relevant systems
• Assess Aperture's architecture against 21 CFR Part 11 requirements for electronic records, audit trails, and electronic signatures
• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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
• Regular and reliable attendance is expected.
• Other work-related duties as assigned by supervisor/manager.

Minimum Knowledge, Abilities, and Skills Required

Education/Experience

• 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, specialty pharmacy, 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

Preferred

• Experience validating cloud-native or containerized applications (AWS, Kubernetes)
• Direct experience with Anovo's stack: AWS, Core .NET, React, PostgreSQL, AWS EKS/Kubernetes, Argo CD, Microsoft Entra ID
• Experience in specialty pharmacy, rare disease, or orphan drug therapy environments
• CSV/CQV certification (e.g., ISPE, ASQ CQE, or equivalent)
• Experience validating systems in HIPAA-regulated environments alongside Part 11
• Familiarity with validation considerations for AI/ML-enabled systems

This description is intended to be only a general outline of major activities. It is expected that the employee performs these and any other activities which may be assigned, or which may occur in the normal course of work. This description is not a contract or guarantee of employment. AnovoRx is an Equal Opportunity Employer.