Job Description
Must have experience from Lyophilizers OEM (Original Equipment Manufacturers of LYO)
Key Responsibilities
- Looking for SME for lyophilization across development, scale up, and commercial manufacturing.
- Experience in maintenance and qualification of CEM/Lyophiliser/HVAC/Utility/Mechanical/Water/ and RPHPLC systems in GMP environments is desired.
- Lead cycle development, optimization, and technology transfer
- Support lyophilizer qualification (IQ/OQ/PQ) and troubleshooting
- Review batch records, SOPs, change controls, deviations, and CAPAs
- Drive root cause investigations and continuous improvement initiatives
- Ensure GMP and regulatory compliance;
support audits and inspections - Exposure to equipment lifecycle management, including calibration, preventive maintenance, and deviation handling aligned with DRL quality systems is prefer...