Lyophilizer Operator

GUFIC BIOSCIENCES LIMITED; Indore District; On-site; INR 300,000 - 600,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED in Indore is seeking a Lyophilizer Operator to operate and monitor lyophilization processes on sterile products, ensuring compliance with approved SOPs and batch manufacturing records.

You will handle loading/unloading, monitor critical parameters, perform cycle runs, clean and sanitize equipment, maintain 5S and EHS practices, and coordinate with Production, QA, Engineering and Maintenance to ensure batch readiness and data integrity.

Responsibilities

• 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.

Job description

• 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.