Senior GMP PLC/HMI Software Remediation Engineer/ Immediate Hiring

• Review and modify legacy PLC ladder logic and HMI programming
• Implement audit trails, user roles, password controls and security
• Troubleshoot alarms, process logic, recipes, timers and system controls
• Support 21 CFR Part 11 / GMP compliance
• Perform and document approved PLC/HMI software changes
• Support Software FMEA and risk assessment
• Prepare technical specifications and change-control documentation
• Support IQ/OQ/PQ, CSV and validation testing
• Resolve software-related validation deviations
• Coordinate with QA, validation, engineering and regulatory teams
• Maintain controlled deployment with minimal impact on production operationsRole & responsibilities

Preferred candidate profile

Remediation of a legacy PLC/HMI-based GMP sterilization system, including audit trails, user access, password controls, software changes, 21 CFR Part 11 compliance, FMEA, and validation support.