Validation Engineer III

ICU Medical•Austin, TX

About The Position

The Validation Engineer III completes validation activities, including writing and executing protocols and performing qualification and validation status assessments. The role handles intermediate to advanced projects with minimal guidance, working independently and collaboratively while seeking input from senior engineers when appropriate. It applies validation strategy and regulatory knowledge to support manufacturing equipment, utilities, facilities, and technology-transfer projects. The position may supervise others during project-specific activities and train employees on documentation, equipment use, laboratory techniques, and department procedures.

Requirements

Must be at least 18 years of age.
Bachelor’s degree from an accredited college or university.
4–7 years of validation, science/technical, or engineering experience.
Solid understanding of validation and regulatory requirements.
Solid understanding of validation strategy and ability to recommend solutions to critical issues.
Ability to make significant decisions that directly affect the success of one or more projects or adjacent workgroups/functions.
Advanced technology-transfer, process, and cleaning validation knowledge.

Nice To Haves

Pharmaceutical validation or engineering experience.
Familiarity with other areas of domain expertise within the team.

Responsibilities

Provide guidance on and execute validation activities for manufacturing equipment, utilities, and facilities to support validation and technology-transfer projects.
Write validation plans, protocols, and reports for specific projects.
Conduct validation risk assessments related to projects, facilities, and products.
Independently collect, organize, and evaluate validation data, and keep validation management informed of progress and obstacles.
Analyze problems of diverse scope and complexity, evaluate relevant data, and use creative approaches to solve complex problems.
Integrate subsystems and components into total systems designs.
Develop specifications based on customer requirements.
May supervise others during project-specific activities.
Train new and current employees on documentation, equipment use, laboratory techniques, and department procedures.
May provide input on performance evaluations to the area manager.
Communicate appropriately with managers, peers, and customers to support cross-functional collaboration.
Address substantive conflicts collaboratively and work to build consensus.
Work on special projects as they arise.