Florence Braddy

Senior Validation Test Engineer @Certara

Charleston, SC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2023 — Present

Senior Validation Test Engineer @Certara

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Lead validation strategy and execution, ensuring GxP compliance and consistent audit readiness• Act as primary validation SME, representing validation processes, documentation, and quality controls• Own the end-to-end validation lifecycle (planning, execution, review, approval) • Drive automation initiatives within formal validation, improving scalability and efficiency of testing in regulated environments• Partner cross-functionally with Engineering, Product, and Quality to ensure requirements are testable, risks are identified early, and defects are resolved effectively• Oversee regression testing and quality gate processes, supporting high-quality, on-time releases• Strengthen traceability and validation practices, contributing to the transition toward unified test management tools across teams • Mentor team members and contractors, providing guidance on validation processes, automation readiness, and testing standards

EDUCATION

N/A

JRS Coding School

Full stack JavaScript development and education program, Computer Software Engineering

2010 — 2013

Kingston University

Bachelor's Degree, Sport Science

2013 — 2015

The Citadel

Master’s Degree, Health, Exercise and Sports Science

SKILLS

SportsU.s. ImmigrationMicrosoft WordPublic SpeakingMicrosoft ExcelPowerpointHigher EducationTeamworkCritical ThinkingSoccer CoachingEvent PlanningGroup LessonsCustomer ServiceTeachingTime ManagementResearchProgram EvaluationLesson PlanningFitnessOrganization SkillsMicrosoft OfficeSocial MediaMarketing

ABOUT FLORENCE BRADDY

Senior Validation Engineer working in GxP-regulated systems within the biopharma space. I focus on building validation strategies that ensure systems are not only compliant, but scalable and efficient as organizations grow.At Certara, I play a key role in validation, partnering with Engineering, Product, and Quality teams to ensure requirements are testable, risks are identified early, and releases are consistently audit-ready. I also act as a validation SME, representing validation processes, documentation, and quality controls.A key part of my work is evolving how validation is approached, driving automation within regulated environments, strengthening traceability, and supporting more risk-based, scalable testing strategies.Core areas of focus:• Validation strategy & lifecycle ownership (CSV)• GxP / CFR Part 11 compliance• Audit readiness & SME support• Test automation in regulated environments• Cross-functional leadership• Requirements traceability

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