Senior Validation Engineer

Otsuka ICU Medical•Austin, TX

19d

About The Position

The Senior Validation Engineer completes advanced, complex validation projects with peer input and guidance from engineering and validation management. This specialist works highly independently, may lead a work group, and may lead validation contract support while tracking validation hours and budget. The role plans and conducts technical projects, develops project scope and solutions, 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. The engineer may coordinate or manage validation and qualification activities for projects, train employees, monitor or supervise their work, and provide performance-evaluation input to the area manager. The position supports inspection readiness, regulatory inspections, and audits; leads continuous improvement for the validation program; and revises, creates, and approves validation documents and procedures. It also develops technical assessments using engineering principles and standards to determine whether existing validation studies can be leveraged for changes that do not represent a new worst case. The position operates primarily in a professional office environment, may involve clean-room work, and typically requires less than 5% travel.

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 that supports the validation strategy and make informed recommendations regarding priorities.
Expertise in equipment, utilities, and facilities validation domains.

Nice To Haves

Pharmaceutical validation or engineering experience.
Familiarity with other areas of domain expertise within the team.
Experience using project management tools.

Responsibilities

Analyze, plan, organize, and complete highly complex projects; develop project scope and creative solutions.
Plan, organize, and conduct technical projects, consolidate design-element results for design review, and integrate subsystems and components into total systems designs.
Develop specifications from customer requirements.
Track project progress and deliver results under general project direction.
Prepare, review, and execute computerized system validation protocols in accordance with local procedures and FDA regulations.
Serve as project coordinator or project manager for validation and qualification aspects of projects.
Communicate with managers, peers, and customers at appropriate frequencies; promote cross-functional collaboration and work collaboratively to resolve conflicts and build consensus.
Manage training for new and current employees on documentation, equipment use, laboratory techniques, and department procedures.
Monitor or supervise the work of employees as needed and provide input on performance evaluations to the area manager.
Work on special projects as they arise.
Support inspection readiness, participate in regulatory agency inspections, and provide audit support as required.
Lead continuous improvement activities for the validation program and revise, create, and approve validation documents and procedures.
Develop technical assessments using engineering principles and standards to support leveraging existing validation studies for changes that do not represent a new worst case.
Lead validation contract support as needed and track validation hours and budget.