Software Validation & Data Security Engineer (Remote)

TestPros delivers innovative independent IT assessment solutions to critical challenges facing the nation and the world.  We support the U.S. Federal Government and Commercial clients within the continental USA. TestPros is dedicated to making lives better, safer and more secure.

Type: Consulting
Duration: Short-Term Project / Project-Based
Client Environment: Healthcare / Regulated Software

Overview:
TestPros is seeking an experienced Software Validation & Data Security Engineer for a part-time, short-term 1099 consulting project supporting hands-on independent validation and verification of a software solution operating in a regulated environment.

The ideal candidate will have experience with software validation, functional testing, data integrity, security testing, and regulatory compliance, along with the technical ability to analyze and scan structured datasets such as CSV, JSON, and databases.

This is a project-based consulting engagement, not a full-time employee position. The consultant will work with TestPros’ security/compliance lead to perform technical testing, document objective evidence, identify exceptions, and support development of the final validation deliverables.

Required Qualifications and Skills

• 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.

  Required Experience:

• 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.

  Preferred Experience:

• 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.

  Ideal Candidate:The ideal candidate is not simply a compliance or GRC professional. We are looking for someone who can personally perform the technical testing and validation, work directly with application and data environments, analyze larger CSV/JSON/database datasets, automate testing where appropriate, and produce clear evidence supporting an independent validation conclusion.

This is best suited for an experienced consultant who is available for a short-term, part-time 1099 project a…