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About the Role

Completes validation activities of writing and executing protocols, performing qualification and validation status assessments. Gains exposure to complex tasks and completes intermediate to advanced projects with minimal guidance.

Responsibilities

Provide guidance and execute validation activities for manufacturing equipment, utilities, and facilities validation to support the validation and tech-transfer projects.
Write validation plans, protocols, and reports for specific projects.
Conduct validation risk assessments related to specific projects, facilities, and products.
Work independently to collect, organize, and evaluate validation data and keep validation management informed of progress and any obstacles.
Works on problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
Largely self-directed after work is assigned.
Uses creative approaches in solving complex problems.
Integrates subsystems and components in total systems design.
Develops specifications from customer requirements.
May supervise others during project-specific activities.
Trains new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
Delivers communications tailored to the needs of the receiver with appropriate frequency to maximize its utility and promote cross-functional collaboration.
Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.
Work on special projects as they arise.

Requirements

Must be at least 18 years of age.
Bachelor’s degree from an accredited college or university is required.
4-7 years of validation, science/technical or engineering background required, pharmaceutical validation or engineering experience preferred.
Has solid understanding of validation and regulatory requirements.
Have a solid understanding of the validation strategy and can recommend solutions to critical issues.
Requires the ability to make significant decisions directly impacting the success of one or more projects, or adjacent workgroups/functions.
Advanced tech-transfer, process and clearing validation knowledge.
Familiar in other areas of domain expertise within the team.
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
Work is performed in a clean room environment.
Must be able to occasionally move and lift objects of up to 25 pounds.

Skills

Validation
Regulatory requirements
Tech-transfer
Process validation
Clearing validation
Communication
Problem-solving
Collaboration
Consensus building

Location

Office environment
Clean room environment

Work Type

Sedentary
Office
Clean room
Travel less than 5%

Experience Level

4-7 years

Education Level

Bachelor’s degree

About the Company

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care.
Each product we make helps ensure patients receive the therapies they need without disruption.
When you work here, you become part of something bigger—a team dedicated to reliability and innovation.
No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.
We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
Join us and help shape the future of IV solutions.

Equal Opportunity

Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com.
We are committed to providing equal access and opportunities for all candidates.