Senior Validation Engineer - Lead Complex FDA Projects

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

Job summary

Otsuka ICU Medical LLC in Austin, TX seeks an experienced validation leader to manage complex pharmaceutical validation projects, lead teams, and help optimize validation processes. You will coordinate with engineering, quality, and regulatory groups to ensure successful execution within scope and budget.

The role requires a bachelor’s degree and 7+ years in validation or related engineering, with strong knowledge of FDA regulations and IQ/OQ/PQ protocols.

Qualifications

• Bachelor’s degree required or equivalent in science/engineering.
• 7+ years of validation, science/technical or engineering background required; pharmaceutical validation experience preferred.
• Experience with FDA regulations and validation protocols (IQ/OQ/PQ) is essential.
• Project management tools experience is a plus.

Responsibilities

• Analyze, plan, and complete complex validation projects.
• Lead validation/qualification activities and coordinate with cross-functional teams.
• Prepare and execute validation protocols per FDA requirements.
• Drive continuous improvement of validation processes and documents.
• Manage training of staff on procedures and equipment use.
• Provide audit support and participate in inspections when required.

Skills

Validation expertise

Regulatory knowledge

Project management

Facilities validation

Education

Bachelor's degree

Job description

Otsuka ICU Medical LLC in Austin, TX seeks an experienced validation leader to manage complex pharmaceutical validation projects, lead teams, and help optimize validation processes. You will coordinate with engineering, quality, and regulatory groups to ensure successful execution within scope and budget.

The role requires a bachelor’s degree and 7+ years in validation or related engineering, with strong knowledge of FDA regulations and IQ/OQ/PQ protocols.