Software Validation & Data Security Engineer (Remote)

TestPros•Sterling, VA

3d•Remote

About The Position

TestPros is seeking an experienced Software Validation & Data Security Engineer for a part-time, short-term 1099 consulting project. This role involves hands-on independent validation and verification of a software solution operating in a regulated environment, specifically within the healthcare sector. The ideal candidate will possess expertise in software validation, functional testing, data integrity, security testing, and regulatory compliance. They should also have the technical capability to analyze and scan structured datasets like CSV, JSON, and databases. This is a project-based consulting engagement, not a full-time employee position. The consultant will collaborate with TestPros' security/compliance lead to conduct technical testing, document evidence, identify exceptions, and contribute to the final validation deliverables.

Requirements

Experience performing software validation, QA, IV&V, or computer system validation (CSV).
Hands-on experience with functional software testing.
Experience developing or executing IQ, OQ, and/or PQ protocols.
Knowledge of FDA 21 CFR Part 11.
Understanding of HIPAA, PII, PHI, privacy, and data integrity requirements.
Experience with Python and/or SQL for data analysis, querying, or automated testing.
Ability to work with CSV, JSON, databases, and large datasets.
Experience with data querying, automated scanning, pattern/identifier detection, or sensitive-data discovery.
Ability to document testing methodology, evidence, findings, and exceptions in a formal validation environment.
Must be comfortable working as a 1099 independent contractor on a part-time, project-based basis.

Nice To Haves

Healthcare, pharmaceutical, life sciences, medical device, or other regulated-industry experience.
Experience with de-identification, data masking, anonymization, PII/PHI detection, or data classification.
Experience developing automated validation scripts or test automation.
Familiarity with ISO 16175-1 and/or ISO 14641.
Experience with records management or electronic document/records systems.
Security testing experience involving access controls, authentication, logging, audit trails, and data protection.

Responsibilities

Perform hands-on software validation and verification testing.
Review system requirements, existing validation documentation, and prior IQ/OQ/PQ documentation.
Develop and/or execute validation plans, test cases, protocols, and test scripts.
Conduct functional testing to confirm system features operate as intended.
Validate data integrity, audit trails, access controls, authentication, and security-related functionality.
Support validation against applicable requirements, including FDA 21 CFR Part 11 and HIPAA.
Perform technical analysis of structured data, including CSV, JSON, and database datasets.
Use automated techniques and scripts to query and scan larger datasets.
Identify sensitive information and patterns, including PII/PHI and other identifiers.
Perform database queries, pattern matching, exception analysis, and data validation.
Document test results, findings, supporting evidence, exceptions, and remediation/retesting.
Support development of a repeatable validation and testing methodology.
Assist with preparation of final validation/IV&V reports and supporting documentation.
Participate in client technical discussions and requirements clarification.