- 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.
📌 Senior GMP PLC/HMI Software Remediation Engineer/ Immediate Hiring (Pune)
🏢 MindZita
📍 Pune