Senior Validation Engineer: Lead Complex FDA Validation

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX is seeking a senior validation professional to lead complex validation projects, with guidance from engineering and validation management. The role is highly independent and may assume a team lead position for the work group.

You will prepare validation protocols, collaborate across functions, and ensure compliance with FDA regulations. Travel is limited, and you will mentor staff while driving continuous improvement in the validation program.

Qualifications

• Bachelor's degree from an accredited college or university.
• 7+ years of validation, science/technical or engineering background required.
• Pharmaceutical validation or engineering experience preferred.

Responsibilities

• Analyzes, plans, organizes and completes projects of a very complex nature.
• Develops scope and provides creative solutions.
• Plans, organizes and conducts technical projects.
• Consolidates results of design elements of major projects for design review.
• Integrates subsystems and components in total systems design.
• Develops specifications from customer requirements.
• Receives general project direction.
• Responsible for project progress.
• Prepares, reviews, and executes validation protocols per FDA regulations.
• Lead continuous improvement activities for the validation program.

Skills

Validation expertise

Regulatory knowledge

Project management

Cross-functional collaboration

Education

Bachelor's degree

Job description

Otsuka ICU Medical in Austin, TX is seeking a senior validation professional to lead complex validation projects, with guidance from engineering and validation management. The role is highly independent and may assume a team lead position for the work group.

You will prepare validation protocols, collaborate across functions, and ensure compliance with FDA regulations. Travel is limited, and you will mentor staff while driving continuous improvement in the validation program.