Peyton St. Clair
Memphis
Summary
Goal-driven Validation Engineer with over 2 years of experience specializing in ensuring equipment and system compliance within regulated industries. Strong knowledge of Good Manufacturing Practices (GMP), FDA regulations, and ISO Standards. Detail-oriented, with a focus on delivering high quality projects on time and improving operational efficiency through continuous improvement practices.
Overview
3
3
years of professional experience
Work History
Validation Engineer
Charles River Laboratories
12.2022 - Current
- Utilize appropriate investigation methods, root cause analysis, and Failure Modes and Effects Analysis (FME) techniques to perform and evaluate validation projects, ensuring production processes of products consistently meet quality standards and specifications.
- Employ Kaye Validator System, RH/Temp Probe and Transmitters, Process and Multimeters, and other test equipment in the execution of validation projects.
- Adhere to FDA, EU, ISPE, USP, ISO, 21 CFR Part 11, and GAMPS regulatory requirements while performing validation projects.
- Generate documents including test scripts, qualification validation protocols, summary reports, and test scripts for commissioning, qualification, and validation of systems and equipment, using established standards and templates.
- Ensure accurate maintenance and updating of validation documentation through validation lifecycle within QMS.
- Verify accuracy of P&IDs, ETOPs, datasheets, specifications, other engineering documents, and other design deliverables from ETOPs.
- Establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability.
- Author operational, maintenance, and calibration procedures for production equipment, test equipment, and utilities.
- Direct design, development, and improvement of manufacturing processes and provided technical support for specific operations.
- Train fellow team members and leadership on proper usage and closure of work order within CMMS, such as BMRAM and Maximo.
QA Regulatory & Validation Intern
Charles River Laboratories
08.2022 - 12.2022
- Augmented an existing program to improve accuracy and efficiency for future use within CMMS.
- Researched and created an informational presentation on Airflow Visualization studies to cross-train several departments.
- Gained hands-on experience in various software programs, increasing proficiency and expanding technical skill set.
Education
Bachelor of Science - Biomedical Engineering
University of Memphis
Memphis, TN12-2022
Skills
- Technical Writing
- Microsoft Office
- Computerized Maintenance Management System (BMRAM and Maximo)
- Ability to work under pressure
- Cross-Functional Collaboration
- Test Plan and execution
Timeline
Validation Engineer
Charles River Laboratories
12.2022 - Current
QA Regulatory & Validation Intern
Charles River Laboratories
08.2022 - 12.2022
Bachelor of Science - Biomedical Engineering
University of Memphis
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