- Operate and monitor Lyophilizer (Lyo) equipment as per approved SOPs and batch manufacturing records.

- Perform loading and unloading of sterile products/trays into the lyophilizer as per defined procedures.

- Monitor critical process parameters such as shelf temperature, product temperature, chamber pressure, vacuum, condenser temperature, and cycle parameters.

- Execute lyophilization cycles as per approved recipes and manufacturing instructions.

- Perform equipment line clearance and ensure the equipment and surrounding area are ready before operation.

- Check equipment status, utilities, alarms, and operating conditions before and during the batch.

- Record process parameters and observations accurately in BMR/BPR, logbooks, and relevant documents.

- Follow cGMP, SOPs, aseptic practices, data integrity, and safety requirements.





- Carry out cleaning and sanitization of the lyophilizer and associated equipment as per approved procedures.

- Coordinate with Production, QA, Engineering, and Maintenance teams for smooth execution of batches.

- Report equipment abnormalities, process deviations, breakdowns, and other issues to the concerned supervisor.

- Assist in troubleshooting operational issues related to the lyophilizer.

- Ensure proper handling of sterile products during loading, unloading, and transfer activities.

- Maintain housekeeping and comply with 5S and EHS requirements.

- Participate in qualification, validation, preventive maintenance, and equipment-related activities when required.

- Ensure all activities are performed in accordance with applicable GMP and regulatory requirements.

📌 Lyophilizer Operator (Indore)
🏢 Gufic Biosciences
📍 Indore