1. Equipment Maintenance & Troubleshooting:Perform routine and preventive maintenance of equipment used in vaccine manufacturing processes, including fermenters, bioreactors, autoclaves, vial filling lines, and utility systems.Identify, troubleshoot, and resolve equipment failures and breakdowns to minimize downtime.
2. Process Optimization:Collaborate with production teams to enhance equipment performance and process efficiency.Recommend and implement engineering modifications to improve operational reliability.
3. Calibration & Validation:Conduct regular calibration and validation of critical equipment to comply with Good Manufacturing Practices (GMP) and regulatory standards.Ensure all instrumentation meets precision and accuracy requirements.
4. Documentation & Compliance:Maintain detailed records of maintenance activities, equipment logs, and calibration schedules.Ensure compliance with safety standards, environmental guidelines, and regulatory requirements (FDA, WHO, etc.).
5. Support for New Installations:Assist in the installation, commissioning, and qualification of new equipment and machinery.Provide engineering support for upgrades and expansions of existing facilities.
6. Utility Management:Oversee and maintain critical utilities such as HVAC, water systems (WFI, RO), steam systems, and compressed air systems essential for vaccine production.
7. Team Collaboration:Work closely with cross-functional teams, including Quality Assurance, Production, and Validation, to ensure seamless operations.Provide training to production and maintenance staff on equipment operation and safety protocols.
8. Instrumentation Maintenance & Calibration:Perform regular maintenance, calibration, and troubleshooting of instrumentation used in vaccine manufacturing, such as pressure sensors, flow meters, pH probes, temperature sensors, and data loggers.Ensure instruments comply with industry standards and regulatory requirements.
9. Automation Systems Management:Operate, monitor, and maintain automation systems, including Distributed Control Systems (DCS), Supervisory Control and Data Acquisition (SCADA), and Programmable Logic Controllers (PLC).Develop and modify control system logic and Human Machine Interface (HMI) for process optimization.
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