SME - Lyophilizer
Dr. Reddy's Laboratories
- Location
- Vishakhapatnam, Andhra Pradesh, India
- Job type
- Full-time
About the role
Dr. Reddy's Laboratories
Website:
drreddys.com
Job details:
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
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