Validation Engineer III

Otsuka 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, with guidance from more experienced engineers and managers. The role handles intermediate to advanced projects with minimal guidance and is generally independent and collaborative. It involves exposure to complex tasks and occasional direction in aspects of the work. The engineer supports manufacturing equipment, utilities, facilities validation, and validation and tech-transfer projects. The role conducts project-related risk assessments, collects and evaluates validation data, develops project specifications from customer requirements, and communicates progress and obstacles to validation management. It may include supervising project-specific activities, training employees, and providing input on performance evaluations. The position requires a solid understanding of validation and regulatory requirements and the ability to recommend solutions to critical issues. It operates in a professional office and clean room environment, is largely sedentary, and typically requires less than 5% travel.

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 background.
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 impact the success of one or more projects or adjacent workgroups/functions.
Advanced tech-transfer, process, and clearing validation knowledge.

Nice To Haves

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

Responsibilities

Provide guidance and execute validation activities for manufacturing equipment, utilities, and facilities to support validation and tech-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, evaluating identifiable factors in the data.
Use creative approaches to solve complex problems.
Integrate subsystems and components in total systems design.
Develop specifications from customer requirements.
Supervise others during project-specific activities when needed.
Train new and current employees in documentation, equipment use, laboratory techniques, and department procedures.
Provide input on performance evaluations to the area manager when needed.
Tailor communications to managers, peers, and customers, with appropriate frequency to support collaboration.
Raise substantive conflicts and disagreements and attempt to resolve them collaboratively and build consensus.
Work on special projects as they arise.