Performing as expert Validation engineer/Process Engineer in the field of Pharmaceutical and Medical Device Industry. Certified as EIT by Texas Board of Professional Engineers after clearing the FE exam.
* Experience in operations, quality and Statistical Process Control.
* Knowledge in diverse topics such as Analytical Chemistry, Statistics, Validation/Verification analysis, engineering operations, FDA Regulations and ISO Regulations.
ASPEN Plus, Minitab, JD Edwards, Microsoft Office Suite (Excel, Word, PowerPoint, Word)
04/2015 to Current
Engineer IIRevere IT － Herndon, VA.
Terumo CVS, Ann Arbor.
Client Location Production Quality Assurance.
Review and provide feedback for engineering analysis (Lab studies) performed to analyze the critical parameters for the process validation.
Review, draft and provide feedback for technical reviews as part of OQ, PQ and design transfer phases of process validation.
Work as quality engineer for day to day production of chemistry strips which is used for measuring the concentrations of CO2, O2, pH and K+ in the blood during heart surgery.
Align Manufacturing work instructions (SOPs) to follow good documentation practice and not losing traceability during the process.
Updated PFMEA and Process validation assessment documents to align with changes in Manufacturing Work Instructions (SOPs).
Replaced a subjective test which defines the cure for coated Chemistries by developing specifications with intensity of UV light.
Performed an engineering analysis for developing a correlation of the UV intensity values in between two radiometers of different light sensitivity.
Review and approve GR&R Test Method Validation's used during the process for acceptance.
Examples include Osmometer, Vernier Calipers, Peel Tester and Force Gage.
Evaluate and Investigate Non conformances in day to day manufacturing process.
Performed GR&R Analysis using Minitab for various equipment for the data obtained from Test Method Execution.
Investigated final release test failure of O2 chemistry.
Performed thorough Root Cause Analysis to identify the issues with the help of Fish Bone Diagram in Minitab.
Experience in analyzing normal and non-normal data for process Capability Analysis (Cpk and Ppk).
Experienced in using various Statistical techniques for historical data or data from the DOEs.
Authored Lab studies to support various validation activities.
Familiarity with FDA Quality System regulations 21 CFR Part820, 21 CFR Part 211.
Familiarity with ISO regulations, risk management for medical devices 14971 and Quality system for medical devices 13485.
01/2014 to 04/2014
Chemical Engineering GraduateIllinois Institute of Technology － Chicago, USA
Studied the functions and methods of manufacture of different types of fuel cells which are commercialized for the daily usage.
Presented a paper on the catalyst to be used in MOFC to increase the efficiency of the fuel cell.
Proposed a solution of the production of hydrogen from the renewable sources for making the fuel cells more sustainable in the real world.
Education and Training
MS: Chemical EngineeringIllinois Institute of TechnologyUSAChemical Engineering GPA: 3.2/4.0
BS: Chemical EngineeringOsmania UniversityChemical Engineering GPA: 3.4/4.0
Attended seminars on "Blood Component Activation: Implications for Thrombotic Events in Rotary Pump", "Engineering Efficient Thermoelectric from Large-scale Nanowire Assemblies" organized by the Chemical and Biological Engineering Department at Illinois Institute of Technology in 2014.
* Head of the Department of Logistics at CHEMSPARK 2012 organized by the department of Chemical engineering, CBIT.
Academic Achievements & Certifications Certified as EIT by Texas Board Of Professional Engineers Secured 2nd place for a paper on the treatment of Industrial waste water by USAB reactor in Ripples 2010 a national level technical symposium at The Andhra University. Secured 858th place out of 200,000 people in an examination equivalent to SAT for undergraduate admission. Activities Attended seminars on "Blood Component Activation: Implications for Thrombotic Events in Rotary Pump", "Engineering Efficient Thermoelectric from Large-scale Nanowire Assemblies" organized by the Chemical and Biological Engineering Department at Illinois Institute of Technology in 2014. Head of the Department of Logistics at CHEMSPARK 2012 organized by the department of Chemical engineering, CBIT.