Samuel Leyva
Mexico,MA
Summary
Pharmaceutical Engineer in Mexico with more than 11 years of experience in Validation, technology transfer and quality systems areas looking for professional growth and new challenges .
Demonstrated ability to work in dynamic environments, different kind of projects and meeting the required results. In addition, participating and manage multifunctional projects, always under the premises of innovation and continuous improvement.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Validation Specialist
Merck
11.2019 - Current
- Coordinate and execute Aseptic Process Simulation.
- Coordinate Filter Validation with service suppliers.
- Periodic qualification review for controlled temperature equipment (autoclaves, incubators, depirogenation ovens).
- Process performance qualification (PPQ).
- Technology transfer for sterile and non-sterile products.
- Cold chain and transport routes validation.
- Deviations, change controls and risk assessments handling.
Senior Validation Engineer
Pfizer
09.2017 - 09.2019
- Critical systems qualification.
- Equipment qualification.
- Implementation of process design (validation step 1) for packaging processes, using lean six sigma tools.
- Process performance qualification (PPQ) for non-sterile products.
- Deviations, change controls and risk assessments handling.
Technical and Scientific Affairs Specialist
Teva Pharmaceuticals
02.2012 - 11.2016
- Qualification of controlled temperature equipment.
- Technology transfer and PPQ of sterile and non- sterile products.
- Cleaning Validation.
- Critical systems qualification.
- Coordinate validation activities in projects for new facilities.
- Deviations, change controls and risk assessments handling.
Education
Bachelor of Science - Pharmaceutical Engineer
Instituto Politécnico Nacional
Ciudad De México12.2010
Skills
- Validation Testing
- Leadership
- Change Control Management
- Problem-Solving
- Team work
- Organizational Skills
- Analytical Thinking
- Supervision and Leadership
- Verbal Communication
- Task Prioritization
Certification
Yellow Belt Certification.
Drugs Robust Development Certification.
Languages
Spanish
Native or Bilingual
English
Professional Working
Timeline
Senior Validation Specialist
Merck
11.2019 - Current
Senior Validation Engineer
Pfizer
09.2017 - 09.2019
Technical and Scientific Affairs Specialist
Teva Pharmaceuticals
02.2012 - 11.2016
Bachelor of Science - Pharmaceutical Engineer
Instituto Politécnico Nacional
Similar Profiles
Casandra L Santiago-NievesCasandra L Santiago-Nieves
IPT/Shop Floor Controller at MerckIPT/Shop Floor Controller at Merck
Kushal PalliKushal Palli
Team Lead at MerckTeam Lead at Merck
Jessica BakerJessica Baker
Executive Hospital Specialty Representative at MerckExecutive Hospital Specialty Representative at Merck
Avery PruittAvery Pruitt
Operations Technician at MerckOperations Technician at Merck
Juan Ramirez Siordia CarlosJuan Ramirez Siordia Carlos
Credit and Collection Manager at AT&TCredit and Collection Manager at AT&T