Validation Engineer

cGxPServe
Miami, FL
Roles & Responsibilities:
  • Walk through production lines, understand equipment and production processes.
  • Understand the current state information from site leaders and functional managers.
  • Understand current challenges and projects in place to improve performance.
  • Understand the project priorities, milestones, staffing needs and timelines.
  • Quality Document GAP Assessment, Alignment & Remediation
  • To understand Production Quality Issues and their root causes
  • Strong knowledge in application of Statistical rationale, in resolving operational problems.
  • Process validation experience.
  • Warehouse optimization, Line/Plant transfer experience.
  • Lead quality improvements and cost reduction projects.
  • Work closely with operations and the Business functions to ensure quality performance of product and process.
  • Understand KPI "s for monitoring of process and/or Product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Posted 2025-08-07

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