Senior Validation Engineer

ICU Medical•Austin, TX

About The Position

Completes advanced, highly complex validation projects with peer input and guidance from engineering and validation management. The role requires substantial independence and may include serving as a team lead, project coordinator, or project manager for validation and qualification work. The engineer may also lead validation contract support and track validation hours and budgets. The position plans, organizes, and conducts technical projects; develops project scope and creative solutions; consolidates design elements for design review; integrates subsystems and components; and develops specifications from customer requirements. It prepares, reviews, and executes computerized system validation protocols in accordance with local procedures and FDA regulations. Decisions may affect multiple or critical business projects and external relationships. The role supports cross-functional collaboration through audience-appropriate communication and collaborative resolution of conflicts. It trains employees on documentation, equipment use, laboratory techniques, and department procedures, and may monitor or supervise employees and provide performance-evaluation input to the area manager. Additional work includes special projects, inspection readiness, regulatory inspections, audit support, continuous improvement, and creating, revising, and approving validation documents and procedures. The engineer develops technical assessments using engineering principles and standards to support leveraging existing validation studies for changes that do not represent a new worst case.

Requirements

Bachelor’s degree from an accredited college or university.
At least 7 years of validation, science/technical, or engineering background.
Must be at least 18 years of age.
Advanced understanding of validation and regulatory requirements.
Ability to assess work in support of the validation strategy and make insightful recommendations regarding priorities.
Expertise in validation for equipment, utilities, and facilities.

Nice To Haves

Pharmaceutical validation or engineering experience is preferred.
Experience using project management tools is a plus.

Responsibilities

Analyze, plan, organize, and complete projects of a very complex nature.
Develop project scope and creative solutions; plan, organize, and conduct technical projects.
Consolidate design elements of major projects for design review and integrate subsystems and components into total systems designs.
Develop specifications from customer requirements and remain responsible for project progress.
Prepare, review, and execute computerized system validation protocols according to local procedures and FDA regulations.
Serve as project coordinator or project manager for validation and qualification aspects of projects.
Tailor communications to managers, peers, and customers to support effective communication and cross-functional collaboration.
Address substantive conflicts and disagreements collaboratively and build consensus.
Train new and current employees in documentation, equipment use, laboratory techniques, and department procedures.
Routinely monitor or supervise the work of one or more employees when needed and provide performance-evaluation input to the area manager.
Support inspection readiness, participate in regulatory agency inspections, and provide audit support as required.
Lead continuous improvement activities for the validation program.
Revise, create, and approve validation documents and procedures.
Develop technical assessments using engineering principles and standards to support use of existing validation studies for changes that do not represent a new worst case.
Work on special projects as they arise.
May lead validation contract support and track validation hours and budget.