Alex R. M.
Sr. Commissioning, Qualification, and Validation Engineer
- Role
- Computer Systems Validation Analyst at axogen
- Location
- Tampa, FL, US
- LinkedIn followers
- 500 followers
About Alex R. M.
As a Validation Engineer, Mechanical Engineer, and Computer System Validation (CSV)…
Experience
Computer Systems Validation Analyst
Sep 2025 — Present · Tampa, FL, US
As a Computer System Validation Analyst at Axogen, I ensure compliance of GxP-regulated software and digital systems through risk-based validation, periodic reviews, and lifecycle management aligned with FDA 21 CFR Part 11, 820, 1271, and EU Annex 15. My work safeguards data integrity, product quality, and operational reliability across Axogen’s IT and manufacturing environments.Key Responsibilities & Contributions:Lead and execute Periodic Reviews for validated systems across manufacturing, quality, and clinical domains, ensuring continued compliance and technical integrity.Perform Computer System Validation (CSV) activities following GAMP 5 and CSA principles, including drafting and executing URS, IQ/OQ/PQ protocols, and risk assessments.Collaborate with IT, QA, and Manufacturing Engineering to maintain system readiness and alignment with internal SOPs (e.g, SOP-0933, QS-0012, WI-0194).Support the acquisition and validation of emerging AI-driven technologies aimed at improving data analytics, process automation, and manufacturing efficiency at Axogen’s Ohio production sites.Contribute to Axogen’s digital transformation initiatives by integrating modern AI tools within a validated framework that upholds regulatory and data integrity standards.Core Competencies:CSV | CSA | GAMP 5 | 21 CFR Part 11 | Annex 15 | Data Integrity (ALCOA+)| AI in Manufacturing | Quality Systems | Risk Assessment | Periodic Review | Validation Lifecycle | Digital Transformation
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