Perform preventive, predictive, and breakdown maintenance of equipment used in sterile injectable manufacturing areas.
Attend equipment breakdowns promptly and ensure timely troubleshooting and restoration to minimize production downtime.
Support the maintenance of manufacturing equipment such as filling machines, washing machines, sterilization equipment, lyophilizes, autoclaves, HVAC systems, and utilities, as applicable.
Execute maintenance activities according to approved SOPs, schedules, cGMP requirements, and safety standards.
Support equipment installation, commissioning, and qualification activities, including IQ, OQ, and PQ.
Assist in preparing and reviewing engineering documents such as equipment history cards, maintenance checklists, logbooks, qualification protocols, and reports.
Ensure timely completion of preventive maintenance, calibration, and equipment qualification schedules.
Coordinate with Manufacturing, Quality Assurance, Validation, EHS, and other departments for smooth engineering operations.
Coordinate with external vendors for equipment servicing, troubleshooting, spare parts, and technical support.
Maintain the availability of critical spare parts and support inventory monitoring and procurement activities.
Support engineering-related QMS activities, including deviations, CAPA, change controls, incident investigations, and risk assessments.
Conduct root-cause analysis for recurring breakdowns and implement corrective and preventive actions.
Ensure adherence to cGMP, Good Documentation Practices, data integrity, regulatory, and safety requirements.
Travel Estimate
Job Requirements
Education Qualification
B.Tech/M.Tech
Experience
Tenure: 1-2 Years
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Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).