
System Validation Specialist
2 weeks ago
Our organization seeks a seasoned system validation expert to ensure seamless integration of IT and OT systems. As a key advisor, you will play a vital role in maintaining regulatory compliance and quality standards.
Key Responsibilities:- Develop and execute comprehensive validation protocols for IT and OT systems.
- Lead risk-based validation efforts aligned with GxP, FDA, and EU MDR requirements.
- Collaborate with cross-functional teams to drive process improvements enhancing quality, compliance, and efficiency.
- Utilize data analysis tools like Excel and Minitab to inform decision-making.
Requirements:
- 5+ years of experience in computer system validation or software assurance in a regulated environment.
- Proven expertise in developing validation plans, protocols, and risk assessments.
- Strong understanding of IT/OT systems, including MES, SCADA, ERP, LIMS, and Data Historians.
- Excellent communication and documentation skills.
Benefits:
- Opportunity to work with a forward-thinking organization.
- Chance to leverage your expertise to drive business growth.
- Professional development opportunities.
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