IT Validation Specialist
We are seeking a skilled IT validation professional to lead system assurance efforts across our clients' critical systems.
You will act as a key advisor to IT teams, ensuring systems meet regulatory and quality standards.
This is a dynamic, hands-on role supporting both enterprise IT environments.
Key Responsibilities:
* Lead system validation and computer software assurance for IT systems
* Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation)
* Provide risk-based validation guidance aligned with GxP, FDA, and EU MDR requirements
* Partner cross-functionally with QA, IT, Engineering, and Manufacturing teams
* Support system improvements that enhance quality, compliance, and efficiency
* Utilize tools like Excel and Minitab for data analysis and reporting
Requirements:
* 5+ years of experience in computer system validation or software assurance in a regulated environment
* Deep knowledge of 21 CFR Part 11, ISO 13485, and GAMP/CSA methodology
* Strong understanding of IT systems (e.g., MES, SCADA, ERP, LIMS)
* Proven experience developing validation plans, protocols, and risk assessments
* Excellent communication and documentation skills
Bonus Points:
* Experience validating manufacturing automation systems (MES, PLC, SCADA)
* ASQ Software Quality Engineer certification
* Familiarity with Six Sigma or TQM principles
Why You'll Thrive:
* Opportunity to work on complex system validation projects
* Collaborative team environment with experienced professionals
* Continuous learning and development opportunities