Software Validation, Data Security Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct independent software validation and verification testing through hands-on methods.

• Review system specifications, existing validation documentation, and previous IQ/OQ/PQ records.

• Create and/or implement validation strategies, testing cases, protocols, and scripts.

• Execute functional testing to ensure system features perform as expected.

• Validate the integrity of data, audit trails, access controls, authentication, and security functionalities.

• Assist in compliance validation with FDA 21 CFR Part 11 and HIPAA standards.

• Analyze structured data formats such as CSV, JSON, and database datasets.

• Employ automated methods and scripts to query and scan extensive datasets.

• Detect sensitive information and patterns, including PII/PHI and other identifiers.

• Execute database queries, pattern recognition, exception analysis, and data validation tasks.

• Record test outcomes, findings, supporting evidence, exceptions, and remediation/retesting efforts.

• Aid in the development of a consistent validation and testing process.

• Contribute to final validation/IV&V reports and related documentation.

• Engage in technical discussions with clients and clarify requirements.

• Collaborate with TestPros' security/compliance lead on technical testing and validation outputs.

⛳️ Requirements

• Proven experience in software validation, QA, IV&V, or computer system validation (CSV).

• Practical experience in functional software testing.

• Background in developing or executing IQ, OQ, and/or PQ protocols.

• Familiarity with FDA 21 CFR Part 11.

• Understanding of HIPAA, PII, PHI, privacy, and data integrity regulations.

• Proficient in Python and/or SQL for data analysis, querying, or automated testing purposes.

• Capability to work with CSV, JSON, databases, and extensive datasets.

• Experience with data querying, automated scanning, pattern/identifier detection, or sensitive-data discovery.

• Ability to document testing processes, evidence, findings, and exceptions in a structured validation setting.

• Comfortable working as a 1099 independent contractor on a part-time, project-specific basis.

• Preferred experience in healthcare, pharmaceuticals, life sciences, medical devices, or other regulated industries.

• Preferred experience in de-identification, data masking, anonymization, PII/PHI detection, or data classification.

• Preferred experience in developing automated validation scripts or test automation.

• Familiarity with ISO 16175-1 and/or ISO 14641 is a plus.

• Preferred experience with records management or electronic document/records systems.

• Background in security testing that involves access controls, authentication, logging, audit trails, and data protection is advantageous.

🏝️ Benefits

• Competitive compensation package.

• Flexible work schedule.

• Opportunity to work in a dynamic and collaborative environment.

• Professional development and growth opportunities.