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Software Validation, Data Security Engineer
TestPros, Inc.. Perform hands-on independent software validation and verification testing .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in software validation and verification testing, with a strong focus on compliance with FDA 21 CFR Part 11 and HIPAA requirements. Proficient in data analysis using Python and SQL, and skilled in developing validation plans and automated testing methodologies.
Highest-signal resume keywords
Software Validation ExperienceFunctional Testing ExperienceFDA 21 CFR Part 11 KnowledgePython and SQL ProficiencyData Integrity and Security Compliance
ATS Keywords
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Hard Skills
Software ValidationFunctional TestingIQ/OQ/PQ Protocol DevelopmentData AnalysisAutomated TestingDatabase QueryingPattern DetectionData ValidationTest DocumentationData Masking
Soft Skills
Independent Contractor ExperienceClient CommunicationRequirements Clarification
Tools & Technologies
CSVJSONDatabasesAutomated Testing ScriptsValidation Documentation
Industry Keywords
HealthcarePharmaceuticalLife SciencesMedical DeviceRegulated IndustryISO 16175-1ISO 14641Records ManagementElectronic Document SystemsData Protection
Tech Stack
Tools & technologiesPythonSQL
About the role
Key responsibilities & impact- Perform hands-on independent 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 FDA 21 CFR Part 11 and HIPAA requirements
- Analyze 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 final validation/IV&V reports and supporting documentation
- Participate in client technical discussions and requirements clarification
- Work with TestPros' security/compliance lead on technical testing and validation deliverables
Requirements
What you’ll need- Experienced software validation, QA, IV&V, or computer system validation (CSV) experience
- Hands-on functional software testing experience
- 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
- Comfortable working as a 1099 independent contractor on a part-time, project-based basis
- Healthcare, pharmaceutical, life sciences, medical device, or other regulated-industry experience preferred
- Experience with de-identification, data masking, anonymization, PII/PHI detection, or data classification preferred
- Experience developing automated validation scripts or test automation preferred
- Familiarity with ISO 16175-1 and/or ISO 14641 preferred
- Experience with records management or electronic document/records systems preferred
- Security testing experience involving access controls, authentication, logging, audit trails, and data protection preferred