
Data Integrity Specialist
2 weeks ago
We are seeking a skilled professional to lead validation and assurance efforts across critical systems.
Key Responsibilities:- Lead validation and Computer Software Assurance (CSA) for IT and OT 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
- Support system and process improvements that enhance quality, compliance, and efficiency
- 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 (e.g., MES, SCADA, ERP, LIMS, Data Historians)
- Proven experience developing validation plans, protocols, and risk assessments
- Excellent communication and documentation skills
- Experience validating manufacturing automation systems (MES, PLC, SCADA)
- ASQ Software Quality Engineer certification
- Familiarity with Six Sigma or TQM principles
This is a dynamic, hands-on role supporting both enterprise IT and operational technology environments. The ideal candidate will possess strong technical skills, excellent communication skills, and the ability to work effectively in a team environment.
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