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Main purpose of the Job/Role : Shall be responsible for Installation and efficient maintenance of Liquid injectable manufacturing equipment .
Job Responsibility:
Attend to breakdowns, troubleshoot and rectify basic issues in shortest possible time and to ensure upkeep of the equipment
Effective communication with original equipment manufacturer to address / resolve the repetitive issues
Prepare Equipment installation drawings and ensure the installation of the equipment as per the same
Trend the breakdowns /concerns of the equipment and implement corrective actions to improve the reliability of the equipment
Review drawings issued by vendor
Prepare specifications for process equipment
Complete periodic inspections of the vendors site to check for the progress of manufacturing of the equipment
Plan and execute preventive maintenance
Ensure that all safety instructions and measures are strictly observed
Study and review standby facilities for critical sub-assemblies and addition of capital equipment on long term basis for smooth operation
Prepare monthly reports
Preparation and Review of respective Documents / Procedures
Execution of Spare Parts management
Supporting for the required reliability initiatives at Site
After Completion of Preventive Maintenance and Corrective Maintenance, ensuring all the data is captured in CMMS
Extending required support during Walkthroughs, Internal Audits & Regulatory Audits
Requirements:
Graduate / Diploma Engineer in Mechanical or Chemical Engineering
4-6 yrs of experience in maintenance function of Liquid injectable manufacturing equipment
Perform routine and preventive maintenance on Fill finished lines Like: Vial Washer, Tunnel, Filling and capping equipment and Solution preparation equipment’s
Able to set the Fill finished line equipment’s as pe the respective vial or ampoule formats changeover
Troubleshoot on Fill fineish lines and Solution preparation equipment’s
Collaborate with operations and engineering teams to improve system reliability and performance
Ensure compliance with safety standards, industry regulations, and quality protocols
Assist in the installation and commissioning of new instrumentation systems
Participate in audits and inspections, providing technical support and documentation as needed
Support equipment qualification and validation processes (IQ/OQ/PQ)
Execution of spare parts & Inventory
Should have Knowledge on Installation, Operation and Maintenance of upstream equipment
Knowledge on qualification program (URS/FAT/SAT/DQ/IQ/OQ/PQ)
Knowledge on operation and maintenance of respective utility / equipment / system
Knowledge of preventive and breakdown maintenance
Should be conversant with Validation Documents, Preventive Maintenance Schedules/Check sheets, SOP’s & Various Audit Procedures
Documentation review skills
Knowledge on Clean room requirements and Regulatory Guidelines
Effective problem solving capabilities
Excellent Interpersonal, written and communication skills