Validation Engineer III

Title: Validation Engineer III Location: Plano, TX (100% Onsite) Duration: 8 Months (Possibility of Extension) Pay Range: $40/hr to $42/hr (On W2) Shift Time: 8am to 5pm We are looking for a “Validation Engineer“ to join one of our Fortune 500 clients. Job Summary: Responsible for ensuring that all non product software systems used in regulated environments—such as manufacturing, quality systems, laboratories, service, and business operations—are validated, compliant, and maintained in accordance with internal quality processes and external regulatory requirements. This role ensures that software supporting business and quality operations is reliable, controlled, and fit for its intended use. Top Skills: Experience in software validation in a regulated industry (medical device, pharmaceutical, biotech, aerospace, automotive, etc.) Knowledge of SDLC, validation methodologies, and strongly committed to QMS processes. Familiarity with regulatory standards related to software in regulated environments. Strong attention to detail and documentation quality. Job Responsibilities: Software Validation & Compliance – Lead and execute validation activities for non product software systems following industry standards (e.g., GAMP 5, ISO, FDA 21 CFR Part 11, Part 820, EU MDR). Develop, review, and approve validation deliverables, including: User Requirements Specifications (USR); Risk Assessment, Validation Plans, Test Protocols (IQ); Traceability Matrices, Validation Report. Ensure software and digital tools meet compliance requirements for electronic records, electronic signatures, data integrity, and cybersecurity. Design Verification & Validation – Understands and applies basic Design Verification and Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records. Quality System Support – Support the deployment, upgrade, and change control of quality management systems (QMS), manufacturing systems (MES), lab systems and other software tools. Maintain validated state through periodic reviews, revalidation, and documentation updates. Cross‑Functional Collaboration: Partner with Quality Assurance, Operations, and cross-functional teams to define software requirements, assess risks, and ensure proper Software/System Test Lifecycle Management (SLC/STLC) Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc. Also ensure risk-based approaches are consistently applied throughout validation. Reviews software design and validation documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Participates on project teams and technical change review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products. Education: B.S. in Computer Science; Software Engineering; Biomedical Engineering, an equivalent combination of education and work experience. Minimum 5 years’ engineering experience and demonstrated use of quality tools/methodologies. Ability to manage multiple priorities and work independently. Excellent analytical, problem solving, and communication skills. Experience working with cross functional teams. Preferred Skills: NPS (Non‑Product Software) ownership responsibilities 5+ years experience covering the entire design control process in a team-oriented environment Knowledgeable of FDA 21 CFR 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971 guidelines and FDA 21 CFR Part 11. Advanced computer skills, including statistical/data analysis and report writing skills.   We are looking for the candidate who are eligible to work with any employers without sponsorship. If you’re interested, please click “Apply” button

Created: 2026-04-01