Job Title: Data Validation Specialist
We are seeking a skilled professional to lead validation and assurance efforts across critical systems.
About the Role:
* Lead validation and Computer Software Assurance (CSA) for IT and OT systems, ensuring compliance with regulatory standards.
* Develop and execute protocols (IQ/OQ/PQ/PPQ, Test Method Validation) using GAMP/CSA methodology.
* Provide risk-based validation guidance aligned with industry requirements.
* Partner cross-functionally with QA, IT, Engineering, and Manufacturing teams.
* Support system and process improvements that enhance quality, compliance, and efficiency.
* Utilize tools like Excel and Minitab for data analysis and reporting.
Key Requirements:
* 5+ years of experience in computer system validation or software assurance in a regulated environment.
* Deep knowledge of 21 CFR Part 11, 21 CFR 820, ISO 13485, and GAMP/CSA methodology.
* Strong understanding of IT/OT systems, including MES, SCADA, ERP, LIMS, Data Historians.
* Proven experience developing validation plans, protocols, and risk assessments.
* Excellent communication and documentation skills.