Validation Engineer III

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Otsuka ICU Medical LLC seeks an engineer to complete validation activities, write protocols, and assess qualification statuses under guidance. The role exposes you to advanced tasks while enabling independent and collaborative work on projects related to manufacturing equipment, facilities, and processes.

You will perform risk assessments, collect data, and communicate progress to management. Opportunities to supervise and train others are possible as you contribute to standardized documentation

Qualifications

• 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.

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.
• Largely self-directed after work is assigned. May solicit input from senior level engineers.
• 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. May provide input on performance evaluations to area manager.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) 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.

Education

Bachelor’s degree

Job description

Position Summary

Completes validation activities of writing and executing protocols, performing qualification and validation status assessments with guidance from more experienced engineers and managers. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work and is generally independent and collaborative in nature. Completes intermediate to advanced projects with minimal guidance from more experienced engineers and managers

• 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. May solicit input from senior level engineers.
• 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. May provide input on performance evaluations to area manager.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) 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.

Job Description

Position Summary

Completes validation activities of writing and executing protocols, performing qualification and validation status assessments with guidance from more experienced engineers and managers. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work and is generally independent and collaborative in nature. Completes intermediate to advanced projects with minimal guidance from more experienced engineers and managers

Essential Duties & 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. May solicit input from senior level engineers.
• 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. May provide input on performance evaluations to area manager.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) 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.

Knowledge & Skills

• 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.

Minimum Qualifications, Education & Experience

• 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.

Work Environment

• 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
• T ypically requires travel less than 5% of the time

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

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.

EEO Statement

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 [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants