Senior QA Validation Engineer

Danaher • Chaska, MN

71d

About The Position

The Senior QA Validation Engineer is responsible for assisting in the sustainment of a robust Master Validation Plan and support of the MVP strategies. This position reports to the Quality Assurance Manager responsible for Validation and is part of the Quality Assurance - Validation department located in Chaska, MN and will be an on-site role. In this role, you will have the opportunity to train and mentor individuals and validation teams (both formal classroom and informal) to ensure efficiency and compliance with validation regulations and corporate procedures. You will evaluate specifications for requirements and ensure they meet validation standards, generate test cases and procedures from specifications with minimal guidance, execute test procedures with minimal guidance and document results accurately, and apply Danaher Business System tools to make continuous improvements across the business.

Requirements

• Bachelor's degree in a relevant field with 5+ years of experience, OR Master's degree in a relevant field with 3+ years of experience, OR Doctoral degree in field.
• Experience in software, test method, equipment, process, and/or design testing methodologies.
• Knowledge of FDA regulations, ISO standards, and GxP guidelines.
• Experience with Computer System Validation (CSV) and process validation.

Nice To Haves

• Experience in IVD Medical device or Pharmaceutical Manufacturing.
• ASQ Certification.

Responsibilities

• Train and mentor individuals and validation teams to ensure efficiency and compliance with validation regulations and corporate procedures.
• Evaluate specifications for requirements and ensure they meet validation standards.
• Generate test cases and procedures from specifications with minimal guidance.
• Execute test procedures with minimal guidance and document results accurately.
• Apply Danaher Business System tools to make continuous improvements across the business.

Benefits

• Comprehensive health care program.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree