SME - Lyophilizer

Dr. Reddy's · Visakhapatnam, Andhra Pradesh · Posted 25 days ago

About this role

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,