Role & responsibilities: -
Equipment Maintenance: Manage preventive, predictive, and breakdown maintenance for core OSD machinery including FBE, High-Speed tablet Compression M/c, Tablet Coating M/c, Capsule Filling, and Blister Packaging lines and Bottle Packing lines to minimize downtime.
Should have positive knowledge and understanding of wiring diagram , PLC , SCADA, 21 CFR electronic systems .
Regulatory Compliance: Ensure maintenance, operations, and facilities strictly adhere to global pharmaceutical standards, including USFDA, MHRA, and WHO-GMP guidelines.
Should have knowledge of MTTR and MTBF and implementing ideas to reduce MMTR and increase MTBF.
QMS Documentation: Should have knowledge of engineering Quality Management System (QMS) processes, including managing Change Controls, Deviations, Investigations, and implementing CAPAs with zero data integrity lapses.
Qualification & Validation: Execute and document Installation Qualification (IQ) and Operational Qualification (OQ) for recent and modified process equipment and utility systems.
Trouble shooting : Manage the trouble shooting of instrumentation and process control devices.
Audit Readiness: Serve as the subject matter expert during internal and external regulatory audits to defend maintenance logs, engineering history, and standard operating procedures (SOPs).
SAP & Automation: Leverage SAP (PM Module) for managing work orders, tracking spare parts inventory, and documenting equipment history sheets.
Team & Vendor Leadership: Supervise, train, and guide shift technicians and junior engineers while coordinating effectively with external OEM vendors for specialized technical support.
Preferred Candidate Profile: -
Required Experience: - 4 to 10 Years
Required Educational Qualification: - B.E. / B.Tech./M.E./ M.Tech (Electrical , Electronics, Instrumentation, Mechanical)
Regards, Human Resources Team,
Intas Pharmaceuticals SEZ Plant
📌 Sr Officer / Executive Engineering Plant Maintenance Osd Ahmedabad (India)
🏢 Intas
📍 India