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Principal Engineer - Containers & Combination Devices

Req #: JR - 065980 Location Round Lake, Illinois, United States Job Category: Engineering Date Posted: 06/23/2022

Overview

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Engineer at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Problem Solver
  • Analytical Thinker
  • Data Driven
  • Solution Focused & Results Oriented
  • Collaborative
  • Innovative

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Principal Engineer - Containers & Combination Devices

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Pharmaceutical Container Closure / Combination Device Engineer

What you’ll be doing:

As an engineer in the  Innovation and Engineering Team within Baxter Pharmaceuticals R&Dorganization (a global business unit of Baxter Healthcare Corporation), you’ll beleading and supporting the design, development, and commercialization of combination drug/ medical device products, pharmaceutical delivery and packaging systems.

The Container & Combination Device Engineer (CCDE) will work on pre-filled syringes, flexible film and other drug container and delivery systems, leading the design, verification and validationof parenteral drug containment, administration and packaging systems. You will collaborate withina cross-functional global team environment supporting projects acrossexploratory, development and on-market spheresof Baxter’sextensive and growing product portfolio. As a CCDE you will collaborate with colleagues from other functional areas including Project Management, Formulation Development, Analytical, Clinical Operations, Manufacturing, Regulatory, Quality, Integrated Supply Chain, Human Factors, Systems Engineering, Device Design Engineering, Global Logistics and Secondary Packaging Engineering .


As a Principal Container Closure Engineer, you will contribute to the development and launch of pharmaceutical and combination device / drug products with the following responsibilities:

  • Execute engineering assignments in primary drug container / delivery system design including developingengineering requirements and conducting design, verification / validation activities and undertaking risk management activities (Hazardous Situation Analysis, pFMEA, dFMEA, Use Error Analysis, Risk Assessment & Control table, etc.).

  • Select sound techniques to solve problems and make design recommendations.

  • Partner with key collaborators (internal and external to Baxter) to develop new pharmaceutical productscommencing with container design, formulation development, clinical developmentand drug administration and delivery systems through to final commercialization.

  • Conduct container closure system suitability assessments, accelerated aging and stress analyses, definitive and field shipping studies and reports as well as development history reports.

  • Stay abreast of regulatory and compendial requirements for packaging components, systems and testing requirements.

  • Conduct risk assessments to evaluate components, systems, suppliers, and processes.

  • Fulfill the role of a Product Design Owner (PDO) within Baxter Pharmaceuticals R&D.

  • Participate in Market and User Needs Assessments and following the principals of “Biodesign”, evaluate technologies and develop / refine product concepts capable of filling or exceeding customer needs, as part of Baxter Pharmaceuticals Innovation and Exploratory Process.

  • Provide technical review for packaging component specifications and incoming release testing protocols.

  • Evaluate the impact of supplier change notifications (SNC’s) on NPD and on-market products, molecule projects, packaging specifications, qualification, and regulatory commitments.

  • Collaborate with Clinical and Human Factors Engineering to conduct End-User / patient centric risk management assessments.

    What you’ll bring to Baxter:

  • BS in Engineering (Mechanical, Electro-Mechanical BioMedical, Chemical) Packaging, Materials Science, Pharmaceutical Science, or related field with 5+ years of experience or Masters with 3+ years.

  • 2+years of experience working in the pharmaceutical, medical device, or packaging industries.

  • Strong desire to contribute in a cross-functional team environment while taking personal responsibility for driving assigned tasks to completion.

  • Solid understanding of engineering principals and procedures in a highly regulated medical device / Pharmaceutical environment.


Your Additional Skills are a plus, but not required!

  • Previous experience with parenteral drug products (pre-filled syringe injectable drugs, Flexible IV containers, drug vials, transdermal, subcutaneous, intranasal, etc.).

  • CAD / CAE experience using CREO / Solidworks.

  • Experience in molding of medical grade plastics.

  • Working knowledge of pharmaceutical industry regulatory directives, guidance, and compendial standards for packaging components, container closure systems and testing standards, medical devices (i.e. ISTA, USP, PhEur, & JP, MDR, CFR)

  • Strong innovation and technical problem-solving skills, strategic thinking, and demonstrated ability to identify problems and drive issue resolution / improvements


Additional Information:

  • Occasional travel to Baxter  / Customer sites within the United States and internationally may be required.

  • While the position is being offered as an onsite role and based in Baxter’s R&D Facilities in Round Lake, Illinois, Baxter provides for a flexible home / on-site working environment commensurate with situational business needs.

  • Relocation Assistance to northern Illinois/ southern Wisconsinwill be offered for suitably qualified candidates


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#IND-USGBRD

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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065980

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an Engineering Technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

Quotes

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Sarah – (center) with members of the Baxter Engineering team who initiated a corporate partnership with Society of Women Engineers.

“Initially I thought I would go to medical school and become a doctor, but I remember calling my mom sophomore year in college and saying ‘I’m going to miss my math.’ I realized at that moment that I preferred to be behind the scenes helping patients by making products that will save them..”

Meet Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an engineering technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

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