MS&T Senior Process Engineer

Otsuka ICU Medical; Austin (TX); On-site; USD 120,000 - 170,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX seeks an experienced Engineering Project Specialist to advance complex manufacturing initiatives. You will lead cross-functional teams with engineering management input, drive process improvements, and ensure regulatory compliance across high-stakes projects.

Ideal candidates hold a engineering degree (BS required; MS/PhD preferred) with 7+ years of experience, specialties in mechanical/chemical/industrial/biomedical engineering, and readiness to travel <5%. GMP change control & validation experience is essential.

Qualifications

• Bachelor's degree in engineering is required; a master's or PhD is strongly preferred.
• 7+ years' experience with a bachelor's degree or 5 years' experience with a PhD.
• Preferred specialties: Mechanical, Chemical, Industrial, or Biomedical engineering.

Responsibilities

• Lead and manage very complex engineering projects with input from management and cross-functional partners.
• Develop project scope, plan technical deliverables, and ensure regulatory compliance across GMP processes.
• Provide technical guidance to Validation Coordinator and project support teams; collaborate with vendors and internal partners.
• Support startup of new equipment, software, or processes; apply GMP change control and validation processes.

Job description

Job Description Position Summary

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.

Essential Duties & Responsibilities

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.

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