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 preferred.
Experience in standardization of engineering practices across sites, including documentation, vendor coordination, and compliance...