Lead Validation Engineer - Complex Systems & Compliance

ICU Medical; Austin (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

ICU Medical in Austin, TX seeks an experienced Validation professional to lead complex validation projects with cross-functional teams. You will manage qualification programs, coordinate validation activities, and ensure compliance with FDA regulations.

This role requires deep knowledge of validation strategies and strong collaboration with engineering and management. The ideal candidate has 7+ years in validation or engineering, a Bachelor's degree, and the ability to drive continuous

Qualifications

• Bachelor's degree from an accredited college or university.
• 7+ years of validation, science/technical or engineering background required; pharmaceutical validation/engineering experience preferred.
• Must be at least 18 years of age.
• Typical travel less than 5% of the time.

Responsibilities

• Analyzes, plans, organizes and completes complex validation projects.
• Receives general project direction and manages progress.
• Prepares and executes computerized system validation protocols per FDA regulations.
• Lead validation-related project coordination or management.
• Deliver communications to managers, peers, and customers to maximize utility.
• Mentor/train employees on documentation, equipment, and lab procedures.
• Support inspections readiness and regulatory audits.
• Lead continuous improvement for the validation program.

Skills

Validation expertise

Regulatory knowledge

Facilities validation

Project management tools

Education

Bachelor's degree

7+ years validation/engineering

Job description

ICU Medical in Austin, TX seeks an experienced Validation professional to lead complex validation projects with cross-functional teams. You will manage qualification programs, coordinate validation activities, and ensure compliance with FDA regulations.

This role requires deep knowledge of validation strategies and strong collaboration with engineering and management. The ideal candidate has 7+ years in validation or engineering, a Bachelor's degree, and the ability to drive continuous