Engineering - PM - Sr. Executive
Job Description
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.