Summary
Overview
Work History
Education
Skills
References
Timeline
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Carlos Zendejas

Indianapolis,IN

Summary

Results-driven Process Engineer with expertise in process optimization, Kaizen implementation, and root-cause analysis. Proven track record in enhancing production performance within the pharmaceutical manufacturing sector.

Overview

5
5
years of professional experience

Work History

Process Engineer

Stevanato Group - Ompi of America
Fishers, Indiana
01.2024 - Current
  • Led and contributed to numerous continuous improvement and Kaizen initiatives focused on enhancing quality, safety, efficiency, and overall production performance.
  • Collaborated with cross-functional teams to troubleshoot equipment and production issues.
  • Conducted root cause analysis for process deviations and implemented corrective actions.
  • Assisted QA in the QMS Review project for site-specific documentation as a Glass Syringe Production SME.
  • Assisted Supplier Quality as a Glass Syringe Production SME during supplier visits.
  • Assisted in data provisions for supplier-quality claims.
  • Established preventative maintenance programs for relevant equipment used in production processes.

Production Engineer

Stevanato Group - Ompi of America
Fishers, Indiana
08.2021 - 12.2023
  • Assisted in establishing a new pharmaceutical manufacturing site through production line validation and start-up, department planning, and personnel training.
  • Specialization in hot glass formation and production of RTU syringes.
  • Developed and updated operation manuals for production processes and safety procedures.
  • Implemented lean manufacturing techniques such as 5S, Kaizen, Kanban, to reduce waste and improve productivity.
  • Operated and maintained production equipment for pharmaceutical glass manufacturing.
  • Assisted in troubleshooting equipment issues to minimize downtime during operations.
  • Trained personnel in the operation of specialized machinery and best practices for using it safely.
  • Trained at the company HQ in Italy for 18 months.

Education

Bachelor of Science - Mechanical Engineering

Rose-Hulman Institute of Technology
Terre Haute, IN
05-2021

Skills

  • Process optimization
  • Good Manufacturing Practice (GMP)
  • Quality management system
  • Lean manufacturing
  • Continuous improvement
  • Lean Six Sigma Yellow Belt certification
  • Root-cause analysis
  • Data analysis
  • Cross-functional collaboration
  • Team leadership

References

References available upon request.

Timeline

Process Engineer

Stevanato Group - Ompi of America
01.2024 - Current

Production Engineer

Stevanato Group - Ompi of America
08.2021 - 12.2023

Bachelor of Science - Mechanical Engineering

Rose-Hulman Institute of Technology
Carlos Zendejas