MS&T Senior Process Engineer

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking an experienced engineer to lead advanced, complex projects with regulatory compliance. You will plan, integrate subsystems, and guide cross-functional teams while maintaining process reliability and partnering with manufacturing, engineering, and vendors. Strong project management and DOE expertise are required.

The role emphasizes independent work, potential team leadership, and collaboration across functions to drive efficiency and innovation in IV solutions.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Industrial, or Biomedical engineering.
• 7+ years’ experience with a bachelor’s degree or 5 years with a PhD in relevant field.
• Credentialing requirements to perform the essential function of your role at customer locations.

Responsibilities

• Analyzes, plans, organizes and completes projects of a very complex nature.
• Develops scope and provides creative solutions.
• Plans, organizes and conducts technical projects; integrates subsystems and components in total systems design.
• Develops specifications from customer requirements.
• Provides direct project management support including planning, securing funding, technical support to Validation Coordinator, and oversight to project support organizations.
• Implements GMP change control and validation processes.
• Previewing/providing feedback on project deliverables and remediation strategies.
• Collaborates with center functions on product development initiatives.

Skills

Advanced engineering

Project management

Cross-functional collaboration

DOE

Regulatory compliance

Education

Bachelor's degree

Master's or PhD preferred

Engineering specialty: Mechanical, Chemical, Industrial, Biomedical

Job description

Completes advanced engineering projects with peer input and guidance from engineering management to increase yield, maximize capacity, reduce costs, and decrease process variability, while maintaining regulatory compliance. A specialist on complex technical and business matters. Work is highly independent. May assume a team lead role for the work group.

• Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.
• Receives general project direction. Responsible for project progress.
• Decisions consistently affect multiple or critical projects in the business and may impact external relationships.
• 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
• Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.
• Identifies opportunities, develops insights, stimulates new ideas, and implements process improvements in collaboration with manufacturing, engineering, other essential internal partners, and external partners including vendors and project contract support.
• Assists with technically challenging process deviations and their resolution.
• Provides direct support to all commercial pharmaceutical manufacturing and support operations by supplying direct technical expertise and advanced statistical concepts e.g. DOE with focus on process capability and reliability.
• Provide direct project management support including planning, securing funding, technical support to Validation Coordinator, and oversight and guidance to project support organizations.
• Participate in start-up efforts of new equipment, software, or processes.
• Implement changes using GMP change control and validation processes.
• Previewing/providing feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, etc.
• Collaborate with center functions on product development initiatives.
• Work on special projects as they arise

Knowledge & Skills

• Has mastered best practices. Has an advanced understanding of engineering discipline
• Can assess what work supports the product strategy and make insightful recommendations regarding priorities
• Expert in your domain of expertise. Familiar in other areas of domain expertise within the team.

Minimum Qualifications, Education & Experience

• Bachelor’s degree required, a master’s or PhD is strongly preferred. Preferred specialties are: Mechanical, Chemical, Industrial, or Biomedical engineering.
• 7+ years’ experience with a bachelor’s degree or 5 years’ experience with a PhD
  • with all credentialing requirements to perform the essential function of your role at customer locations.

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 with occasional work performed in a clean room environment
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time.
• 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