Validation engineering professional with 10 years of the rich background. Rich background in quality assurance and compliance. Demonstrated success in ensuring compliance with regulatory standards and executing comprehensive validation protocols. Highly collaborative and results-focused, flexible in adapting to project needs and providing reliable support to teams.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Validation Engineer
Fresenius Kabi México, S.A. De C.V.
01.2016 - Current
Responsible for the creation of validation protocol's, as well as the analysis of results and development of improvement projects for processes of:
Coordination and validation of manufacturing processes
Cleaning of facilities
Cleaning in place and sterilization in place
Wet heat terminal sterilization processes
Product distribution qualification
Controlled temperature storage
Risk analysis and change controls
Improvement projects
Experience in the validation of products complying with FDA regulations.
Development of protocols and reports for the validation of manufacturing processes in the food industry.
Retort thermal processes complying with FDA regulations.
Collaborated with other departments to facilitate successful project completion.
Wrote, reviewed and edited technical document in accordance with template requirements.
Developed positive working relationships with stakeholders to effectively coordinate work activities.
Collaborated on interdisciplinary teams for the implementation of improvements.
Handling internal audits and audits by regulatory and corporate entities.
Collaborate with Quality Assurance teams during audits as an internal auditor.
Validation Analyst
Laboratorios PiSA SA De CV.
03.2013 - 12.2015
Perform protocols, plans, reports and validation annexes
Handle good manufacturing practices and good documentation practices.
Coordinate and execute wet heat sterilization precesses.
Coordinate and execute dry heat sterilization precesses.
Coordinate and execute dehydrogenation validations.
Supervise simulated aseptic fills
Maintained up-to-date documentation of all relevant procedures and results, ensuring complete transparency throughout the entire project lifecycle.
Collaborated with cross-functional teams to ensure consistent application of validation standards across projects.
Education
Currently Studying - Information And Computer Systems
Universidad Virtual Del Estado De Guanajuato
Purisima Del Rincón, Guanajuato, México.
Bachelor of Science - Químico Farmacobiología
Universidad Michoacana De San Nicolas De Hidalgo
Morelia, Michoacán, México.
08.2012
Skills
Effective communication
ISO standards
Audit processes
Validation standards
Equipment qualification
Testing protocols
CAPA management
Process validation
Measurements and analysis
FDA regulations
Accomplishments
Coordinación de pruebas de validación para inscripción de productos a la Food and Drugs Administration (FDA) en alimentos.
Participe en proyectos de validación de equipos térmicos en Brasil.
Participe en el proyecto de implementación de la Norma ISO 50001 como Ingeniero de energías.
Certification
Diplomado téorico práctico en formación integral del técnico tequilero- Theoretical-Practical Diploma in comprehensive training for the Tequila Technician- Universidad Michoacana de San Nicolás de Hidalgo.- Universidad Michoacana de San Nicolas de Hidalgo.
Diplomado en inocuidad de alimentos- Diploma in Food Safety-Universidad Michoacana de San Nicolás de Hidalgo
As Prescribed by the Food and drug Administration (FDA), and the Food and Inspection Service, USDA. Better Process Control School- Food Safety International Network.
Timeline
Validation Engineer
Fresenius Kabi México, S.A. De C.V.
01.2016 - Current
Validation Analyst
Laboratorios PiSA SA De CV.
03.2013 - 12.2015
Currently Studying - Information And Computer Systems
Universidad Virtual Del Estado De Guanajuato
Bachelor of Science - Químico Farmacobiología
Universidad Michoacana De San Nicolas De Hidalgo
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