Validation Engineer III

About the Role

We are seeking a Validation Engineer to provide independent quality oversight of non‑product software systems used in regulated environments for a Fortune 500 client. The position is 100 % onsite in Plano, TX, for a 12‑month contract.

Key Skills

• Experience providing quality oversight of software validation activities in regulated industries (medical device, pharmaceutical, biotechnology, aerospace, automotive).
• Working knowledge of SDLC, software/system validation lifecycle, and Quality Management System (QMS) requirements.
• Familiarity with regulatory requirements and industry standards governing computerized systems (e.g., GAMP 5, FDA 21 CFR Part 11, 21 CFR Part 820, EU MDR, ISO standards).
• Experience reviewing and approving software validation documentation: requirements, risk assessments, test protocols, traceability matrices, validation reports, change control records.
• Strong attention to detail for assessing documentation accuracy, completeness, consistency, traceability, and compliance.

Responsibilities

• Provide independent quality oversight of non‑product software systems across manufacturing, quality systems, laboratories, service, and business operations.
• Ensure software validation, implementation, maintenance, and change activities comply with internal quality system requirements, applicable regulations, and industry standards.
• Review and approve Non‑Product Software (NPS) lifecycle deliverables to confirm systems are validated, controlled, and fit for intended use.
• Conduct quality review and approval of validation documentation, including URS, risk assessments, validation plans, IQ/OQ/PQ protocols and reports, traceability matrices, validation summary reports, change assessments, and periodic reviews.
• Verify compliance of software and digital tools with electronic records, electronic signatures, data integrity, cybersecurity, and documentation control requirements.
• Review verification and validation strategies, protocols, results, and records to ensure completeness, traceability, objective evidence, and regulatory compliance.
• Provide quality oversight during design reviews and validation activities, ensuring appropriate verification and validation methodologies are applied.
• Partner with product development, IT, manufacturing/operations, engineering, system owners, and other stakeholders to maintain compliance throughout the software/system lifecycle.
• Guide teams on quality system requirements, validation expectations, risk‑based decision making, and documentation practices; facilitate resolution of quality and compliance issues.
• Oversee risk‑based approaches for system implementation, validation, maintenance, and change management; evaluate impact of software changes on validated state, product quality, patient safety, data integrity, and regulatory compliance.

Requirements

• B.S. in Computer Science, Software Engineering, Biomedical Engineering, or equivalent combination of education and experience.
• Minimum 5 years of engineering experience with demonstrated use of quality tools/methodologies, preferably in medical device industry.
• Experience providing Quality Engineering or Quality Assurance oversight for Non‑Product Software (NPS) systems throughout their lifecycle.
• Knowledge of FDA 21 CFR 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971, and FDA 21 CFR Part 11.
• Experience participating in project reviews, validation reviews, change review boards, audit activities, and quality decision‑making processes.
• Proven ability to influence cross‑functional teams and provide objective quality guidance for compliant system implementation and maintenance.

Preferred Qualifications

• GAMP 5 or Computerized System Validation (CSV) training/certification.
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE).

Pay

$40 /hr to $42 /hr (On W2).

Schedule

Shift: 8 am – 5 pm.