Sai Kumar Jampani

Summary

Detail-oriented and motivated engineering professional with a Master of Science in Bioengineering and hands-on experience in a regulated GMP manufacturing environment. Eager to apply a strong understanding of process controls, quality standards, and data analysis to a Design Quality Engineer role. A fast learner with experience following written instructions and standard operating procedures to contribute to the efficient production of medical devices. Seeking to leverage a background in bioprocessing, validation support, and quality analysis to support supplier quality and component manufacturing at Boston Scientific.

Work History

Downstream Assistant

Virchow Biotech Pvt. Ltd

Executed downstream bioprocessing tasks in a manufacturing environment operating under strict GMP guidelines.
Operated and maintained key manufacturing equipment including chromatography skids and filtration systems (TFF, Depth, Sterile), gaining hands-on experience relevant to equipment lifecycles and performance.
Supported documentation and validation support activities, contributing to batch records and ensuring procedures met regulatory standards.
Prepared buffers and maintained optimal process control through pH adjustments and condition monitoring, ensuring process consistency and quality.

Education

Master of Science - Bioengineering & Biomedical Engineering

Wright State University

Dayton, OH

Bachelor of Technology - Biotechnology

Vignan’s Foundation for Science, Technology & Research

Guntur, India

Skills

GMP Compliance
Laboratory Safety
Documentation & Validation Support
Lean Process Engineering
Quality System Regulation (QSR) principles
Filtration Methods (TFF, Depth, Sterile)
Chromatography

Buffer Preparation & pH Monitoring
Microbial Techniques & Cultivation
JMP
MATLAB
Microsoft Office
Spectroscopy (UV/VIS, Mass)

Projects

Statistical Analysis of Swedish Orthopedic Arthroplasty Data, Utilized JMP to evaluate data on revision surgery causes, identifying performance and quality trends in medical implants. This project provided experience in analyzing component performance and driving data-based conclusions relevant to supplier quality. Failure Analysis in Orthopedic Implants, Investigated structural failure in knee liners and plate-screw systems using mechanical modeling. This work is directly applicable to understanding and investigating field failures related to supplier materials. Growth Kinetics of Lactobacillus via Serial Dilution, Experimented with microbial growth conditions and analyzed results to determine ideal cultivation parameters, demonstrating skills in process optimization and control.

Relevant Skills

GMP Compliance, Laboratory Safety, Documentation & Validation Support, Lean Process Engineering, Quality System Regulation (QSR) principles, Filtration Methods (TFF, Depth, Sterile), Chromatography, Buffer Preparation & pH Monitoring, Microbial Techniques & Cultivation, JMP, MATLAB, Microsoft Office, Spectroscopy (UV/VIS, Mass)

Timeline