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Joshua Brown
Validation Specialist
Summary
Validation Specialist with 5+ years of experience in developing and executing validation protocols for computerized systems used in clinical trials. Proficient in functional, performance, and integration testing to verify software and hardware systems meet specifications. Developed test plans and test cases based on user requirements and system specifications. Analyzed test results and identified discrepancies, proposing corrective actions to improve system performance. Collaborated with development and quality assurance teams to ensure validation requirements were met throughout the software development lifecycle. Utilized industry-standard validation tools and techniques, such as GAMP 5, 21 CFR Part 11, and ISO 13485. Participated in risk assessments and audits to identify potential validation gaps and ensure compliance. Trained and mentored colleagues on validation best practices and regulatory requirements.
Education
Master’s degree in Computer Science or a related field
September 2018
Skills
- Validation Test Planning
- Validation Test Execution
- Validation Report Writing
- Validation Protocol Creation
- Quality Assurance Principles
- Risk Assessment
Work Experience
Validation Specialist
- Collaborated with development and quality assurance teams to ensure validation requirements were met throughout the software development lifecycle.
- Utilized industrystandard validation tools and techniques, such as GAMP 5, 21 CFR Part 11, and ISO 13485.
- Participated in risk assessments and audits to identify potential validation gaps and ensure compliance.
- Trained and mentored colleagues on validation best practices and regulatory requirements.
Validation Specialist
- Developed and executed validation protocols for computerized systems used in clinical trials, ensuring compliance with regulatory guidelines.
- Conducted functional, performance, and integration testing to verify software and hardware systems met specifications.
- Developed test plans and test cases based on user requirements and system specifications.
- Analyzed test results and identified discrepancies, proposing corrective actions to improve system performance.
Accomplishments
- Developed and implemented a comprehensive validation plan that reduced validation time by 20% and improved compliance by 15%.
- Collaborated with crossfunctional teams to establish validation criteria and ensure timely execution of validation activities.
- Improved validation efficiency by 10% through the use of automation tools and optimized processes.
- Conducted thorough risk assessments and identified potential hazards, mitigating risks and ensuring product safety.
- Developed a validation master plan that provided a roadmap for all validation activities, ensuring consistency and compliance.
Awards
- Received the Validation Excellence award for outstanding contributions to the validation process and ensuring compliance with industry regulations.
- Recognized for exceptional work in leading the validation of a new product line, meeting all regulatory requirements and timelines.
- Awarded for outstanding performance in developing and conducting validation studies for complex medical devices.
- Received a certificate of recognition for successful completion of a rigorous validation training program.
Certificates
- Certified Validation Specialist (CVS)
- Certified Quality Auditor (CQA)
- Certified Validation Professional (CVP)
- Certified Computer System Validation Specialist (CCSV)
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How To Write Resume For Validation Specialist
- Highlight your experience and expertise in validation testing, specifically in the pharmaceutical or medical device industry.
- Showcase your knowledge of industry standards and regulations, such as GAMP 5, 21 CFR Part 11, and ISO 13485.
- Quantify your accomplishments whenever possible, using specific metrics to demonstrate the impact of your work.
- Proofread your resume carefully and ask a colleague or mentor to review it for feedback.
- Tailor your resume to each job application, highlighting the skills and experience that are most relevant to the specific role.
Essential Experience Highlights for a Strong Validation Specialist Resume
- Develop and execute validation protocols for computerized systems used in clinical trials
- Conduct functional, performance, and integration testing to verify software and hardware systems meet specifications
- Develop test plans and test cases based on user requirements and system specifications
- Analyze test results and identify discrepancies, proposing corrective actions to improve system performance
- Collaborate with development and quality assurance teams to ensure validation requirements are met throughout the software development lifecycle
- Participate in risk assessments and audits to identify potential validation gaps and ensure compliance
- Train and mentor colleagues on validation best practices and regulatory requirements
Frequently Asked Questions (FAQ’s) For Validation Specialist
What is a Validation Specialist?
A Validation Specialist is responsible for ensuring that computerized systems used in clinical trials are compliant with regulatory guidelines. This includes developing and executing validation protocols, conducting testing, and analyzing results. Validation Specialists work closely with development and quality assurance teams to ensure that systems meet specifications and are fit for use.
What are the key skills for a Validation Specialist?
Key skills for a Validation Specialist include validation test planning, validation test execution, validation report writing, validation protocol creation, quality assurance principles, and risk assessment.
What are the career prospects for a Validation Specialist?
Validation Specialists are in high demand in the pharmaceutical and medical device industries. With experience, Validation Specialists can advance to management roles or specialize in specific areas, such as software or hardware validation.
What is the average salary for a Validation Specialist?
The average salary for a Validation Specialist in the United States is around $85,000 per year.
What are the challenges of being a Validation Specialist?
The challenges of being a Validation Specialist include keeping up with changing regulatory requirements, managing complex validation projects, and ensuring that systems are validated in a timely and efficient manner.
What are the rewards of being a Validation Specialist?
The rewards of being a Validation Specialist include making a significant contribution to the development of safe and effective medical products, working with cutting-edge technology, and having a stable and well-paying career.
How can I become a Validation Specialist?
To become a Validation Specialist, you typically need a bachelor’s or master’s degree in computer science or a related field, as well as experience in validation testing and quality assurance.