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.
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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
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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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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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