Validation Engineer III

Title: Validation Engineer III

Location: Plano TX (100% Onsite)

Duration: 12 Months

Shift Time: 8am to 5pm

Pay Range: $40/hr to $42/hr (On W2)

We are looking for a “Validation Engineer“ to join one of our Fortune 500 clients.

• Experience providing quality oversight of software validation activities in a regulated industry (e.g., medical device, pharmaceutical, biotechnology, aerospace, or automotive), with the ability to perform the responsibilities described in the Main Responsibilities section.
• Working knowledge of SDLC, software/system validation lifecycle, and Quality Management System (QMS) requirements.
• Knowledge of regulatory requirements and industry standards governing computerized systems and software used in regulated environments.
• Experience reviewing and approving software validation and lifecycle documentation, including requirements, risk assessments, test protocols, traceability matrices, validation reports, and change control records.
• Demonstrated attention to detail, with the ability to assess documentation for accuracy, completeness, consistency, traceability, and compliance.

• Responsible for providing independent quality oversight of non-product software systems used in regulated environments, including manufacturing, quality systems, laboratories, service, and business operations.
• Ensures that software validation, implementation, maintenance, and change activities comply with internal quality system requirements, applicable regulations, and industry standards.
• Reviews and approves Non-Product Software (NPS) lifecycle deliverables to ensure systems are validated, controlled, and fit for their intended use.
• Quality Oversight & Compliance
• Provide independent quality review and approval of Non-Product Software validation and lifecycle deliverables in accordance with internal procedures, applicable regulatory requirements, and industry standards (e.g., GAMP 5, FDA 21 CFR Part 11, 21 CFR Part 820, EU MDR, ISO standards).
• Reviews software development and validation documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity.
• Review and approve validation documentation, including:
• User Requirements Specifications (URS)
• Risk Assessments
• Validation Plans
• Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports, as applicable
• Traceability Matrices
• Validation Summary Reports
• Change Assessments and Periodic Reviews
• Ensure software and digital tools comply with requirements for electronic records, electronic signatures, data integrity, cybersecurity, and documentation control.
• Verification & Validation Oversight
• Review verification and validation strategies, protocols, results, and associated records to ensure completeness, traceability, objective evidence, and compliance with established requirements.
• Provide quality oversight during design reviews and validation activities to ensure appropriate verification and validation methodologies are applied.
• Cross-Functional Collaboration
• Partner with Product Development, Information Technology, Manufacturing/Operations, Engineering, System Owners, and other stakeholders to ensure compliance throughout the Software/System Lifecycle.
• Provide guidance on quality system requirements, validation expectations, risk-based decision making, and documentation practices.
• Facilitate resolution of quality and compliance issues related to non-product software systems.
• Risk Management Oversight
• Ensure risk-based approaches are consistently applied throughout system implementation, validation, maintenance, and change management activities.
• Evaluate the impact of software changes on validated state, product quality,…