Plant Engineer II

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 75,000 - 105,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin seeks an engineer to drive technical projects and process improvements across pharmaceutical manufacturing operations. You will evaluate existing processes and equipment, propose improvements, assist with implementation, and support validation and startup of new equipment.

With a minimum of two years in manufacturing or process engineering and a bachelor’s degree in engineering, you will analyze performance data, lead troubleshooting, train staff, and collaborate

Qualifications

• Bachelor’s Degree in engineering required; mechanical, chemical, or biomedical preferred.
• Minimum 2 years of manufacturing or process engineering experience.
• Experience in pharmaceuticals or regulated environments is desirable.

Responsibilities

• Analyze performance data to identify continuous improvements.
• Develop SME understanding and lead troubleshooting of issues.
• Support project scopes, design, FAT/SAT, start-up and validation.
• Train new employees and foster cross-functional collaboration.

Skills

Analytical skills

Decision making

Troubleshooting

Cross-functional collaboration

Communication

Education

Bachelor’s Degree in Engineering

Job description

Position Summary

Drives technical projects and improvements for the assigned business unit to enhance the efficiency, quality, compliance, customer service and safety of Austin pharmaceutical manufacturing operations. Evaluate existing processes and equipment, suggest and evaluate improvement alternatives, and assists with implementation of process improvements. Completes intermediate projects with guidance from more experienced engineers and managers. Work closely with maintenance. Provide technical support to project management to secure funding, help plan and execute projects. Provide technical support to Validation.

• Conducts independent analysis and develops solutions to problems. Includes analysis of performance data, including downtime, efficiency, scrap rates etc. to identify, evaluate and implement continuous improvements.
• Develops thorough understanding of assigned processes, working to become SME. Participate in and start to lead troubleshooting of issues arising in existing processes.
• Develops approaches and designs where precedent usually exists.
• Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.
• Writes detailed design specifications. Provides technical input for project scope development and execution.
• Receives general project direction; solicits additional input from more experienced engineers. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work.
• Supports project scope, design, FAT, SAT, start-up, commissioning, and supports validation for new equipment. Participates in large project teams.
• Trains new employees on use of equipment, system and equipment documentation, and department procedures.
• Develops and delivers working relationships and communications tailored to the needs of the receiver (managers, peers, customers, production, quality, and maintenance) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Work on special projects as they arise.

Job Description

Drives technical projects and improvements for the assigned business unit to enhance the efficiency, quality, compliance, customer service and safety of Austin pharmaceutical manufacturing operations. Evaluate existing processes and equipment, suggest and evaluate improvement alternatives, and assists with implementation of process improvements. Completes intermediate projects with guidance from more experienced engineers and managers. Work closely with maintenance. Provide technical support to project management to secure funding, help plan and execute projects. Provide technical support to Validation.

• Conducts independent analysis and develops solutions to problems. Includes analysis of performance data, including downtime, efficiency, scrap rates etc. to identify, evaluate and implement continuous improvements.
• Develops thorough understanding of assigned processes, working to become SME. Participate in and start to lead troubleshooting of issues arising in existing processes.
• Develops approaches and designs where precedent usually exists.
• Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.
• Writes detailed design specifications. Provides technical input for project scope development and execution.
• Receives general project direction; solicits additional input from more experienced engineers. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work.
• Supports project scope, design, FAT, SAT, start-up, commissioning, and supports validation for new equipment. Participates in large project teams.
• Trains new employees on use of equipment, system and equipment documentation, and department procedures.
• Develops and delivers working relationships and communications tailored to the needs of the receiver (managers, peers, customers, production, quality, and maintenance) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Work on special projects as they arise.

Essential Duties & Responsibilities

• Conducts independent analysis and develops solutions to problems. Includes analysis of performance data, including downtime, efficiency, scrap rates etc. to identify, evaluate and implement continuous improvements.
• Develops thorough understanding of assigned processes, working to become SME. Participate in and start to lead troubleshooting of issues arising in existing processes.
• Develops approaches and designs where precedent usually exists.
• Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.
• Writes detailed design specifications. Provides technical input for project scope development and execution.
• Receives general project direction; solicits additional input from more experienced engineers. Gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work.
• Supports project scope, design, FAT, SAT, start-up, commissioning, and supports validation for new equipment. Participates in large project teams.
• Trains new employees on use of equipment, system and equipment documentation, and department procedures.
• Develops and delivers working relationships and communications tailored to the needs of the receiver (managers, peers, customers, production, quality, and maintenance) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Work on special projects as they arise.

Knowledge, Skills & Qualifications

• Competent in your domain. Familiar with other areas of domain expertise within the team.
• Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline.
• Have awareness of the broader equipment strategy and contribute to it.
• Ability to receive general project direction and solicit input from more experienced engineers.
• Requires the ability to independently make decisions that impact the attainment of project objectives.

Education And Experience

• Bachelor’s Degree is required: Any engineering field. Preferred disciplines are: Mechanical, Chemical, or Biomedical engineering.
• Minimum of 2 years of experience required. Preferred experience: manufacturing, utilities engineering or maintenance and / or experience as process engineer implementing improvements in a manufacturing environment.
• Work experience in pharmaceuticals or a regulated environment is desirable.

Minimum Qualifications

• Must be at least 18 years of age.

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements And Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Some work is performed in a clean room environment.
• Must be able to occasionally move and lift objects of up to 25 lbs.

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