Key Responsibilities
- Operate and monitor lyophilization equipment as per batch manufacturing records.
- Prepare and load vials or trays into the lyophilizer according to SOPs.
- Set and monitor critical process parameters such as temperature, vacuum, and cycle duration.
- Ensure uniform drying and product stability during lyophilization.
- Perform in-process checks and ensure compliance with quality standards.
- Conduct routine cleaning, sterilization, and preventive maintenance of lyophilization equipment.
- Maintain accurate batch records, logs, and documentation.
- Identify and report any process deviations, equipment malfunctions, or product defects.
- Coordinate with QA/QC for in-process inspections and approvals.
- Follow aseptic techniques and strict cleanroom protocols.
