Maintenance Operations: Oversee the preventive breakdown and predictive maintenance schedules for all OSD machinery including high-speed Tablet Presses Fluid Bed Processors (FBP) and Auto-coaters.
Automation & PLC/SCADA: Troubleshoot modify and program PLC systems (Siemens Rockwell Mitsubishi) and update SCADA/HMI interfaces for process optimization and recipe management.
Instrumentation Calibration: Manage the calibration and loop testing of critical field instruments sensors and actuators to ensure precise automated controls.
Data Integrity & 21 CFR Part 11: Ensure all computerized systems audit trails electronic records and user access levels strictly comply with ALCOA principles and global regulatory standards.
QMS & Audit Compliance: Lead investigations for engineering deviations implement CAPAs draft Change Controls and represent the automation/maintenance department during regulatory audits (USFDA/MHRA).
Validation & Qualification: Author and execute validation protocols (DQ/IQ/OQ/PQ) for software upgrades computerized systems and newly installed manufacturing equipment.
Spare Parts & Inventory: Manage a cost-effective inventory of critical mechanical electrical and automation spares to guarantee minimum production downtime.
Resource Management: Supervise and train a team of technicians and junior engineers ensuring strict adherence to engineering SOPs and shop-floor safety protocols.
Required Experience:
Senior IC
Maintenance Operations: Oversee the preventive breakdown and predictive maintenance schedules for all OSD machinery including high-speed Tablet Presses Fluid Bed Processors (FBP) and Auto-coaters.Automation & PLC/SCADA: Troubleshoot modify and program PLC systems (Siemens Rockwell Mitsubishi) and up...
Maintenance Operations: Oversee the preventive breakdown and predictive maintenance schedules for all OSD machinery including high-speed Tablet Presses Fluid Bed Processors (FBP) and Auto-coaters.
Automation & PLC/SCADA: Troubleshoot modify and program PLC systems (Siemens Rockwell Mitsubishi) and update SCADA/HMI interfaces for process optimization and recipe management.
Instrumentation Calibration: Manage the calibration and loop testing of critical field instruments sensors and actuators to ensure precise automated controls.
Data Integrity & 21 CFR Part 11: Ensure all computerized systems audit trails electronic records and user access levels strictly comply with ALCOA principles and global regulatory standards.
QMS & Audit Compliance: Lead investigations for engineering deviations implement CAPAs draft Change Controls and represent the automation/maintenance department during regulatory audits (USFDA/MHRA).
Validation & Qualification: Author and execute validation protocols (DQ/IQ/OQ/PQ) for software upgrades computerized systems and newly installed manufacturing equipment.
Spare Parts & Inventory: Manage a cost-effective inventory of critical mechanical electrical and automation spares to guarantee minimum production downtime.
Resource Management: Supervise and train a team of technicians and junior engineers ensuring strict adherence to engineering SOPs and shop-floor safety protocols.
Required Experience:
Senior IC
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