Technical Validation Architect

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.

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.

Education/Experience