Technical Validation Architect

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.