What are the responsibilities and job description for the Technical Validation Architect position at Anovo?
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
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.