G
GUFIC BIOSCIENCES LIMITED
Lyophilizer Operator
Skills
Testing & QA
13 days ago
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Important information
Contract type:
Permanent
Location:
Indore, Madhya Pradesh, India
Work mode:
Onsite
Published on:
7 October 2026
What they need
- 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.
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