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Validation Engineer Resume Example

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VALIDATION ENGINEER
Summary

Dedicated Chemist Pharmaceutical Biologist with excellent technical, analytical and communication skills demonstrated by 2 years of experience.

Bilingual Validation Engineer proudly offering over 2 years' experience in the development and executive of validation master plans. A polished professional and expertise working on validation protocols and ensuring regulatory compliance. Skilled in task prioritization, resolving and ensuring regulatory compliance. Skilled in task prioritization, resolving issues successfully and assessing data.

Dependable professional willing to shoulder various responsibilities, including auditing and testing for the pharmaceutical sector. A smart Validation Engineer known for having exceptional math, communication and decision- making talents.

Skills
  • Pharmaceutical equipment operations
  • Customer service excellence
  • Supervision
  • Quick learner
  • Regulatory guidelines
  • Process improvements
  • Quality assurance requirements
  • English and Spanish translation
  • Operations monitoring
  • Inspection procedures
  • Collecting blood samples
  • Quality assurance
  • Operational improvement
  • Process improvement
  • Behavior modification
  • Privacy and confidentiality
Experience
Ultra Laboratorios S.A De C.V | Guadalajara, JaliscoValidation Engineer04/2019 - 12/2019
  • Inspected, calibrated and tested instruments used to manufacture medical devices.
  • Investigated equipment failures, identified causes and initiated methods to resolve such issues.
  • Identified safety issues and performance trends by performing statistical analysis.
  • Managed supplier key performance indicators and ensured that materials complied with specifications.
  • Provided high level of training to Validation Chemist, thoroughly explaining validation methods and testing procedures.
  • Planned and executed SAT (Site Acceptance testing).
  • Collaborated with production team members to help team create and deliver high quality, cutting-edge products.
  • Supervised 15 staff members to comply with ISO 9001.
  • Documented entire validation process and recorded all changes.
  • Evaluated effectiveness of training by surveying trainees and managers and collecting before-and after-data showing training impact.
  • Provided continuous process improvement and preventative and corrective actions to facilitate operational efficiency.
  • Prepared departmental contracts for attorney approval.
  • Obtained COFEPRIS License ratings during bi-annual quality audits.
  • Trained internal staff members on administrative processes, work instructions and procedures to facilitate consistent and seamless company operations.
  • Presented complex technical data in easily understood terms to individuals without engineering backgrounds.
Solfran Laboratorios | Guadalajara, JaliscoQuality Inspector07/2018 - 03/2019
  • Maintained operations below 95% error rate by verifying strict compliance with established processes.
  • Led cross-functional team evaluations of production metrics and test results.
  • Interpreted and classified production and quality data for pharmaceutical products.
  • Recommended corrective actions to minimize rate of product defects.
  • Analyzed and interpreted blueprints, data and manuals to determine precise specifications.
  • Marked pharmaceutical products with grades and accepted or rejected designations.
  • Analyzed manufacturing data against functional design and expected quality results.
  • Conducted routine visual inspections of the warehouse work to uncover issues with compliance and tolerances.
  • Documented, filed and maintained proper inspection records and quality assurance documents.
  • Measured product dimensions to assess compliance with specifications.
  • Inspected, tested and measured materials, products and installations against specifications.
  • Inspected primary, secondary and final products and work processes to determine compliance.
  • Notified supervisors about production problems and helped identify and correct concerns.
  • Used software system to document job tasks and duties for traceability and transparency.
  • Inspected quality of finished products, making minor repairs to meet project expectations.
  • Trained Quality Inspectors to perform and document quality inspections and audits.
  • Documented inspection information and compiled data into reports for dissemination to management.
  • Assessed finished items for defects and ordered reworks to eliminate irregularities.
Amusement Park Selva Mágica | Guadalajara, JaliscoStaff Photographer02/2017 - 02/2018
  • Carefully maintained over $900 worth of studio equipment.
  • Photographed special events, including parties and school trips portraits.
  • Cropped, manipulated and performed color-balance for final images.
  • Defined image requirements and planned photographic events.
  • Improvised photographic methods and techniques.
  • Set up precise photographic measurements and control equipment.
  • Trained internal staff members on administrative processes, work instructions and procedures to facilitate consistent and seamless company operations.
Education and Training
Centro Universitario De Ciencias Exactas E Ing. | GuadalajaraBachelor of Science in Medicinal And Pharmaceutical Chemistry03/2019
Universidad De Guadalajara | GuadalajaraHigh School Diploma01/2014
Additional Information

I have a degree in Biological Pharmaceutical Chemistry at the University of Guadalajara. I developed professionally 2 years in the pharmaceutical industry and now I want to return to the USA to develop professionally. I am willing to learn and be better personally and professionally.
At the moment I do not have my official certificate of my professional degree since it is pending but I am officially graduated and certified with my degree.

Hobbies

My hobbies are sports, exercise, reading, going out with friends and family, traveling to places surrounded by nature and learning new things. I also like listening to music, photography and watching movies.

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Resume Overview

Companies Worked For:

  • Ultra Laboratorios S.A De C.V
  • Solfran Laboratorios
  • Amusement Park Selva Mágica

School Attended

  • Centro Universitario De Ciencias Exactas E Ing.
  • Universidad De Guadalajara

Job Titles Held:

  • Validation Engineer
  • Quality Inspector
  • Staff Photographer

Degrees

  • Bachelor of Science in Medicinal And Pharmaceutical Chemistry
    High School Diploma

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