Senior Validation Quality Engineer – GMP/ISO

Brighter Signals; Jacksonville (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is recruiting a Senior Validation Quality Engineer for Quality Operations in Jacksonville, FL. The role focuses on FDA/GMP and ISO 9001 compliance and drives risk-based validation across multiple domains.

The ideal candidate has 5–9 years in medical device/pharma QA or regulatory fields, strong data analysis skills, and experience with quality systems. This full-time role emphasizes continuous improvement and regulatory readiness.

Qualifications

• Bachelor’s degree in Science/Engineering/Business required or equivalent.
• Master’s degree preferred for advanced roles.
• 5–9 years of experience in medical device/pharma QA or regulatory fields.
• Thorough knowledge of ISO/FDA regulatory requirements.
• Excellent organizational, interpersonal, written and oral communication skills.
• Root cause analysis experience required.
• Data-driven with knowledge of SPC and applied statistics.
• Ability to analyze data and manage multiple projects simultaneously.

Responsibilities

• Facilitates complex validation activities across product, process, equipment, software and facilities changes in compliance with regulations and policies.
• Tracks and trends quality performance to identify opportunities for improvement and prioritize resolutions.
• Applies a risk-based validation strategy and evaluates change requests.
• Represents QA in validation for multi-department meetings, change control and project teams.
• Compiles data and provides management reports on a periodic basis.
• Develops and trains on quality concepts, policies, documentation and systems as necessary.
• Reviews and updates quality documentation and procedures.

Skills

Quality Assurance

Regulatory Compliance

Root Cause Analysis

ISO/FDA Knowledge

Validation

Data Analysis

Quality Systems

Cross-functional Collaboration

Education

Bachelor’s Degree - Science/Engineering/Business

Master’s degree preferred

Job description

Johnson & Johnson is recruiting a Senior Validation Quality Engineer for Quality Operations in Jacksonville, FL. The role focuses on FDA/GMP and ISO 9001 compliance and drives risk-based validation across multiple domains.

The ideal candidate has 5–9 years in medical device/pharma QA or regulatory fields, strong data analysis skills, and experience with quality systems. This full-time role emphasizes continuous improvement and regulatory readiness.