Edith Salas Gonzalez

BEPC Professional Consulting-Engineer de Validation I

( Jhonson & Jhonson MedTech) 2024-Actual

• Planning, organization, development and management of engineering projects.
• Development of software or specific applications for process automation.
• Evaluation and selection of suppliers and materials for engineering projects.
• Design and development of engineering projects in various areas, complying with quality standards.
• Development and testing of prototype equipment and systems.
• Preparation, maintenance and updating of technical documentation.
• Preventive and corrective maintenance of equipment and components.
• Installation and configuration of equipment and components on new production lines.
• Collaboration in the planning and development of technical projects.
• Validation package for new equipment for the medical industry.

Technician Validation I | 07/2022 -2025

Bepc Consulting - Chihuahua, Juarez Validation Technical

BEPC Professional Consulting ( Johnson & Johnson )

• Validation package (OQ, IQ, PQ, PVE, CSV-E Validation)
• Protocol and Report
• Documentation upload in Windchill system (CN, CR)
• Document approvals
• Equipment registration in EHS
• Equipment registration in PM (Preventive Maintenance)
• Maintenance plan
• Equipment fault codes
• FMECA Equipment category classification (Criticality)
• Equipment calibration (External, Internal) Manufacturing

BEPC Professional Consulting- Technician Validation

( Johnson & Johnson Project EUMDR Regulation FDA) 2022-2025

• PLM Windchill System ( Change Notice, Change Request)
• Validations Test Method Validation
• Confirmation Run Protocols Execute
• Software Validation (Protocols Execute)
• Execute Validations in Manufacturing
• Interpretation of Drawings
• Data Collection ( Minitab Software)
• Update documents the Manufacturing
• ( Minitab Software)
• Regulation FDA

Technician LEAN MANUFACTURING | 12/2021 -07/2022

Becton Dickinson BD Medical - Chihuahua, Juarez

BDPS - BD Production System is adapting to a new production system. Participation in TMS, CSD with activities in the implementation of training lines, improving the reduction of downtime and waste, and enhancing production metrics.

• Certification in TWI (Job Instruction Instructor Course)
• Zero Losses, waste control with greater contribution in the plant.
• Action plans to improve results in production lines.
• Active auditor in the 5S program.
• Design of work standards
• Execution of the Project Charter
• Capacity Study
• Wrap-up in production lines

Continuous Improvement Technician

Continuous Improvement Technician

Support the planning, design, and execution of continuous improvement projects, develop improvement ideas, and drive project execution. Time observations, machine capacity, identification of non-value-added activities. Identification and redesign of stations to eliminate ergonomic, safety, and process waste risks.

• Work area distribution
• Create visual aids
• Yamazumi charts, VA and N/VA charts
• Time studies
• Design and implementation of stations
• Implementation of CR's in the Master Control program
• Completion and filling of forms for the validation process of new projects
• CAPA actions and closures
• 5S audits
• Process Map interpretation
• Execution of the DMAIC Shark project
• Waste analysis
• Workstation manufacturing procedures