Principle Engineer

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.

Your role at Baxter

As a Principal Engineer at Baxter, you will provide technical support to multiple disciplinary product development teams across domestic/international manufacturing facilities, regulatory affairs and internal Sterility Assurance Customers. You will act as a Sterility Assurance Project Lead (Focal Point) for new product development, sustaining product support, and manufacturing facility marginal improvement projects.

Your team:

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

At Baxter, our team values speed, agility, courage and collaboration. We offer autonomy, flexible work environment. Come join our team.

What You’ll be doing:

· Coordinate, prioritize and manage multiple sterility assurance related activity with minimal guidance.

· Perform standard engineering assignments which are typically a significant portion of a larger project. Select sound techniques to solve problems and make design recommendations under direction of supervisor. Assess results for application, validity and conformance to specifications. Recommend material and process specifications.

· Utilize engineering tools to solve straightforward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Mold Flow, SPC, software development).

· Provide input for schedules, Budget, product requirement and Design.

· Provide support for Regulatory Submissions

· Liaise with cross functional project teams and manufacturing facilities to develop validation plan or rationale statement and sterilization parameters for product development.

· Lead and support Product development studies for Baxter and Contract manufacturing facilities associated with the organization.

· Lead agile sterility assurance internal project meetings

· Effectively communicate program status to multidisciplinary project team members, management and key stake holders in Baxter.

· Provide support to complex investigation, troubleshooting and CAPAs.

· Evaluate data/results relative to product requirements, definition and program goals.

· Ability to travel Baxter manufacturing facility or supplier as per requirement.

What You’ll bring:

· Candidate working with a Drug Company (Pharma/ Biopharma preferred but would consider Device). Should have a good knowledge of Regulations and GMP working environment. Exposure to multiple products life cycle desirable.

· Master’s in science /Master’s in Pharmacy/BS Engineering with 12+ years related experience.

· General knowledge of sterilization Modalities and regulatory requirements for sterile medical products and nutrition (Moist heat, Gamma, Ethylene Oxide, Electron Beam, X-rays, Aseptic processing).

· Ability to drive complex decision making and influence course of action using both written and Verbal methods.

· Ability to design experiments, protocols and draw meaningful data using statistical methods such as descriptive, diagnostic, predictive and prescriptive analytics desirable.

· Facilitate cross functional team with minimal guidance and effectively operate projects.

· Ability to provide solutions that reflect understanding of business objectives and cost implications.

· Prepare Rationale statement/ White Papers supporting the project as an when required.

· Experience in handling Change control and CAPA via track wise tool.

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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