- Responsible for maintenance management (Breakdown and Preventive Maintenance) for all manufacturing skids available at the site.
- Should have knowledge about manufacturing and filtration processes of complex skids.
- Should have knowledge about the complete process from raw material sampling/dispensing to finished goods (Sampling / Dispensing / Manufacturing / Filtration / Filling / Capping / Packing).
- Should have knowledge about selection of material for manufacturing and filtration skids based on product/chemicals.
- Should have knowledge about instrumentation and operation of components installed on skids.
- Should have knowledge about critical components such as block valves magnetic mixers transfer pumps manufacturing vessels weighing systems during design of manufacturing and filtration skids.
- Should have knowledge about control systems of the skids.
- Should have knowledge about PLC SCADA IPC.
- Should have knowledge about Zone 1 & 2 safety guidelines.
- Should have capability for installation and commissioning of manufacturing skids.
- Should have experience handling complex manufacturing and filtration skids.
- Should be able to communicate effectively with cross-functional teams (Quality MSTG R&D and Production).
- Should have knowledge about filling line equipment (Washing / Depyrogenation tunnel / Filling / Freeze Dryer / Capping / Leak testing / Inspection / X-ray).
- Should have knowledge about Quality Management Systems (QMS) such as Change Control CAPA Unplanned Deviation Investigation.
- Will act as the Single Point of Contact (SPOC) for manufacturing skid OEMs for technical discussions to establish Good Engineering Practices and monitor preventive maintenance centrally.
- Should be able to prepare SOPs for operation and maintenance of equipment.
- Should have knowledge about calibration activities of instruments.
- Should be able to handle third-party vendors during day-to-day activities and installation of equipment.
- Should have knowledge about execution documentation and coordination with third-party vendors for CSV and PCS (Process Control System) qualification and validation.
- Should have knowledge about SAP system for PM calibration and breakdown maintenance.
- Should manage critical spares of skids such as seals pumps magnetic mixers valves sensors etc.
- As a Subject Matter Expert (SME) should be able to train operators and engineers working on complex skids.
- Should be able to handle project work related to digitization automation and system/equipment upgrades.
- Ensure safety standards are maintained at the site and safety procedures are available and strictly followed in accordance with relevant regulations.
- Should be able to coordinate technically with the procurement team and follow up with vendors for material and project/service work.
- Ensure GMP documents are maintained as per SOP.
- Ensure timely compliance with internal and external audit observation points.
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Responsible for maintenance management (Breakdown and Preventive Maintenance) for all manufacturing skids available at the site.Should have knowledge about manufacturing and filtration processes of complex skids.Should have knowledge about the complete process from raw material sampling/dispensing t...
- Responsible for maintenance management (Breakdown and Preventive Maintenance) for all manufacturing skids available at the site.
- Should have knowledge about manufacturing and filtration processes of complex skids.
- Should have knowledge about the complete process from raw material sampling/dispensing to finished goods (Sampling / Dispensing / Manufacturing / Filtration / Filling / Capping / Packing).
- Should have knowledge about selection of material for manufacturing and filtration skids based on product/chemicals.
- Should have knowledge about instrumentation and operation of components installed on skids.
- Should have knowledge about critical components such as block valves magnetic mixers transfer pumps manufacturing vessels weighing systems during design of manufacturing and filtration skids.
- Should have knowledge about control systems of the skids.
- Should have knowledge about PLC SCADA IPC.
- Should have knowledge about Zone 1 & 2 safety guidelines.
- Should have capability for installation and commissioning of manufacturing skids.
- Should have experience handling complex manufacturing and filtration skids.
- Should be able to communicate effectively with cross-functional teams (Quality MSTG R&D and Production).
- Should have knowledge about filling line equipment (Washing / Depyrogenation tunnel / Filling / Freeze Dryer / Capping / Leak testing / Inspection / X-ray).
- Should have knowledge about Quality Management Systems (QMS) such as Change Control CAPA Unplanned Deviation Investigation.
- Will act as the Single Point of Contact (SPOC) for manufacturing skid OEMs for technical discussions to establish Good Engineering Practices and monitor preventive maintenance centrally.
- Should be able to prepare SOPs for operation and maintenance of equipment.
- Should have knowledge about calibration activities of instruments.
- Should be able to handle third-party vendors during day-to-day activities and installation of equipment.
- Should have knowledge about execution documentation and coordination with third-party vendors for CSV and PCS (Process Control System) qualification and validation.
- Should have knowledge about SAP system for PM calibration and breakdown maintenance.
- Should manage critical spares of skids such as seals pumps magnetic mixers valves sensors etc.
- As a Subject Matter Expert (SME) should be able to train operators and engineers working on complex skids.
- Should be able to handle project work related to digitization automation and system/equipment upgrades.
- Ensure safety standards are maintained at the site and safety procedures are available and strictly followed in accordance with relevant regulations.
- Should be able to coordinate technically with the procurement team and follow up with vendors for material and project/service work.
- Ensure GMP documents are maintained as per SOP.
- Ensure timely compliance with internal and external audit observation points.
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