Mario Gonzalez
Long Beach,CA
Summary
Dedicated Senior Validation Engineer with a strong focus on regulatory compliance and project coordination. Known for developing effective validation strategies and fostering teamwork to achieve project goals and enhance product quality. Results-driven Senior Validation Engineer with expertise in software validation, risk assessment, and regulatory compliance. Proven track record in developing validation protocols and ensuring cross-functional collaboration to meet project deadlines.
Overview
20
20
years of professional experience
Work History
Senior Validation Engineer
CAI
Long Beach, CA
04.2021 - Current
- Validated software systems for compliance with industry standards and regulations.
- Developed test plans and executed validation protocols for critical projects, ensuring compliance with industry standards.
- Collaborated with cross-functional teams to ensure project alignment and requirements.
- Managed multiple projects simultaneously, consistently meeting deadlines and maintaining quality under pressure.
- Facilitated cross-departmental collaboration to enhance project outcomes and ensure timely delivery.
- Developed protocols for validating products against internal and industry standards.
- Reviewed and approved validation documentation for accuracy and completeness.
- Executed equipment qualifications to verify proper functionality and performance.
- Conducted risk assessments to identify validation challenges and implemented solutions to mitigate risks.
- Collaborated with cross-functional teams to ensure compliance with regulatory standards.
- Reviewed technical documentation to confirm accuracy and completeness of specifications.
- Conducted risk assessments to prioritize validation activities effectively.
- Participated in continuous improvement initiatives to enhance validation efficiency and effectiveness.
- Performed risk assessments of validation activities to determine appropriate levels of testing.
- Ensured that all documentation related to validations is properly maintained according to established procedures.
- Participated in internal audits and inspections related to validations programs or other quality assurance initiatives.
- Interacted with external vendors and contractors during the development and implementation stages of validations projects.
- Coordinated the execution of tests and generated reports on the performance of existing systems.
- Provided guidance on regulatory requirements for various types of validations.
- Assisted in troubleshooting production issues by identifying potential root causes through investigations.
- Collaborated closely with cross-functional teams including Quality Control, Manufacturing, R&D, throughout the lifecycle of a project.
- Developed and implemented validation protocols for new processes, equipment, utilities and systems.
- Documented results of validation activities in accordance with FDA guidelines.
- Conducted design reviews of process, equipment and system changes to ensure compliance with regulatory requirements.
- Identified areas where process improvements can be made in order to increase efficiency or reduce costs.
- Maintained current knowledge about industry trends and best practices related to product and process validations.
- Reviewed vendor-supplied documents such as user manuals, drawings, specifications, for accuracy prior to use.
- Collaborated with production team members to help team create and deliver high quality, cutting-edge products.
- Managed supplier key performance indicators and checked materials for compliance with specifications.
- Scheduled validation testing with different departments and managers.
Senior Lab Supervisor
Johnson & Johnson
Los Angeles, California
12.2005 - 03.2021
- Supervised laboratory operations and ensured compliance with safety regulations.
- Developed and implemented standard operating procedures for lab processes.
- Coordinated scheduling and resource allocation for laboratory projects to ensure timely completion and effective use of resources.
- Trained staff on new equipment and laboratory techniques effectively.
- Monitored inventory levels and ordered supplies as needed for operations.
- Collaborated with cross-functional teams to support research initiatives.
- Conducted regular quality control checks to maintain laboratory standards.
- Maintained accurate records of data collected during experiments.
- Kept equipment in good working order and facilities clean, neat and organized.
- Performed CAP studies, biannual CVM tests and daily Quality Control runs.
- Developed and validated analytical methods for testing new products or processes.
- Implemented computerized systems for tracking samples, processing results, and generating reports.
- Attended conferences and seminars related to laboratory sciences to keep abreast of industry developments.
- Developed strategies for improving efficiency within the lab environment through process optimization initiatives.
- Established relationships with vendors and suppliers to secure competitive pricing on essential equipment and supplies, supporting budget management.
- Provided technical guidance and support to laboratory staff on a variety of techniques including chromatography, mass spectrometry, microscopy, imaging analysis.
- Managed quality assurance and quality control programs in accordance with regulatory standards.
- Analyzed test results using statistical techniques to identify trends or anomalies in product performance over time.
- Completed routine sample processing, validations and reagent QC runs.
- Maintained and calibrated lab instruments and equipment to streamline use.
- Evaluated and assessed lab equipment to resolve malfunctions and restore functionality.
- Conducted routine checks on sensitive lab equipment to maintain consistent performance and reliability.
Education
Bachelor of Science - BIOCHEMISTRY
California State University, Northridge
Northridge, CA06-2003
Skills
- Software validation
- Computer system validation
- Test plan development
- Test procedure development
- Manual and automated testing
- End-to-end testing
- Quality assurance
- Quality management systems
- Equipment qualification
- Validation strategy development
- Risk assessment
- Regulatory compliance
- Data integrity assurance
- Good documentation practices
- Quality risk management
- Protocol documentation
- Project coordination
- Cross-functional collaboration
- Technical reporting
- Team collaboration
Timeline
Senior Validation Engineer
CAI
04.2021 - Current
Senior Lab Supervisor
Johnson & Johnson
12.2005 - 03.2021
Bachelor of Science - BIOCHEMISTRY
California State University, Northridge