SME - Lyophilizer

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 is desired.
• Exposure to SCADA/BMS integration, vendor coordination, and harmonization of maintenance practices across multiple sites is preferred.
• Mentor and train teams on lyophilization best practices.

Required Qualifications

• Bachelor’s or Master’s degree in a relevant scientific or engineering discipline
• 12–16 years’ experience in sterile manufacturing with strong lyophilization focus
• Hands on experience with commercial lyophilizers and automated systems
• Strong knowledge of thermal analysis, formulation science, and regulatory expectations