Lead Validation Engineer - GMP & Projects

Otsuka ICU Medical; Austin (TX); On-site; USD 120,000 - 150,000; Full time

Job summary

Otsuka ICU Medical in Austin seeks a senior validation specialist to complete advanced validation projects with input from engineering and validation management. The role is highly independent and may lead a team, including validation contract support and budget tracking.

You will oversee planning, execution, and documentation of validation protocols per FDA regulations, coordinate cross-functional teams, and drive continuous improvement in the validation program.

Qualifications

• Advanced understanding of validation and regulatory requirements.
• Can assess what work supports the validation strategy and make insightful recommendations regarding priorities.
• Expert in equipment, utilities and facilities domains of validation.
• Familiar in other areas of domain expertise within the team.
• Experience using project management tools is a plus.

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 purpose of design review.
• Leads continuous improvement activities for the validation program and revise, create and approve validation documents and procedures.
• Serve as project coordinator or project manager for validation/qualification aspects of projects.

Skills

Advanced validation

Regulatory knowledge

Project management

Cross-functional collaboration

FDA regulations

Education

Bachelor's degree

Job description

Otsuka ICU Medical in Austin seeks a senior validation specialist to complete advanced validation projects with input from engineering and validation management. The role is highly independent and may lead a team, including validation contract support and budget tracking.

You will oversee planning, execution, and documentation of validation protocols per FDA regulations, coordinate cross-functional teams, and drive continuous improvement in the validation program.