Senior Validation Quality Engineer

Johnson & Johnson Vision seeks a Senior Validation Quality Engineer in Jacksonville, Florida to ensure operational compliance with FDA/GMP and ISO 9001 regulations. The role involves managing validation activities, analyzing quality trends, and supporting quality management systems across manufacturing operations.

Responsibilities

• Facilitate complex validation activities for product, process, equipment, software, and facility changes
• Track and trend quality performance data using quality tools to identify improvement opportunities
• Apply risk-based approach to validation strategy and assess change requests
• Represent quality assurance in multi-departmental meetings and project teams
• Develop sampling plans using attribute, variable, and sequential sampling methods

Requirements

• Bachelor's degree in Science, Engineering, or Business; Master's degree preferred
• 5-9 years in medical device/pharmaceutical manufacturing or Quality Assurance
• Thorough knowledge of ISO and FDA regulatory requirements
• Root cause analysis experience and technical problem-solving ability
• Strong Statistical Process Control and Applied Statistics knowledge
• Excellent organizational, written, and oral communication skills
• Ability to manage multiple projects and prioritize quality issues