• Seeking a full-time/contract Position in product development, manufacturing ,industrial,R&D or maintenance engineering.. •Trained and certified in installation and commissioning of LYOPHILIZER(Freeze Dryer). •Experience in identification, assessment and mitigation of possible risk factors which may often incur losses to the organizations. •Experience in validation of materials/final parts according to customer's requirements and supported basic capacity •Strong understanding of 21 CFR's such as 11, 210, 211, 820 including electronic records, electronic signatures, system validation strategies and documentation •Hands on experience in Commissioning, Qualification, Validation of laboratory and analytical equipment, Validation of Process, Change controls, Quality Management System/Compliance •Comprehensive knowledge and extensive experience in technical writing of Validation protocols (Computer System Validation (CSV), Design Qualification (DQ), Facility and Utility Qualification, Installation Qualification - IQ, Operational Qualification - OQ), Validation Master Plan (VMP), SOP's, SAT, Test Summary Report, Test Plans, Test scripts, and Requirement Traceability Matrix (RTM) in FDA regulated environments.
Design of Mechanical Joints • Finite Element Analysis – I • Engineering Analysis •Transport Phenomena – II • Internal Combustion Engines • Advanced Thermodynamics • Mechanics of Composite Materials and Structures • Computational Fluid Dynamics • Applied Thermodynamics • Finite Element Analysis – II • Transport Phenomena – I
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