R&D Sterility Assurance - Project Lead

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Shape the Safety of Life‑Saving Therapies

At Baxter, our mission to save and sustain lives is driven by scientific rigor and regulatory excellence. As an R&D Sterility Assurance Project Lead, you act as a technical focal point, defining and executing robust sterility assurance strategies to ensure product safety, quality, and compliance. You lead sterility assurance activities across complex R&D programs, applying advanced engineering and regulatory principles to solve non‑routine challenges and support multidisciplinary teams that develop, commercialize and support products on the market.

What You Will Do

Sterility Assurance Leadership

• Act as the Sterility Assurance Project Lead / Focal Point for R&D programs.

• Define and execute sterility assurance strategies, including test method validation plans, rationale statements, and sterilization parameters.

• Provide interpretation and guidance on GxP and global sterility regulations.

• Support regulatory submissions related to sterility assurance.

Project & Technical Ownership

• Lead sterility assurance activities with a high degree of autonomy across projects of broad scope.

• Contribute to project planning, budgets, product requirements, and design decisions.

• Communicate status, risks, and recommendations to cross‑functional teams and leadership.

• Serve as a technical liaison with manufacturing facilities (domestic and international).

Innovation & Problem Solving

• Evaluate and adapt sterilization approaches to optimize quality, safety, and cycle time.

• Support microbiology test method validations.

• Assess technical feasibility of complex product and process concepts.

• Introduce new technologies and methods to improve existing and future products.

• Support complex investigations, troubleshooting, and CAPAs.

Collaboration & Knowledge Sharing

• Support product development studies across the R&D lifecycle.

• Provide technical support to R&D, Regulatory Affairs, Manufacturing, and internal Sterility Assurance teams.

• Mentor junior team members and contribute to Baxter’s leadership in sterility assurance.

What You Bring

Experience & Education

• B.S. in Engineering with 5–8 years of experience, or

• M.S. with 2–4 years, or

• Ph.D. with 1–2 years of relevant industry experience.

Technical Expertise

• Strong understanding of engineering principles and cross‑disciplinary collaboration.

• Knowledge of sterilization modalities (Moist Heat, EtO, Radiation, Aseptic Processing preferred).

• Experience in GMP environments and with regulatory expectations for sterile products.

• Ability to design experiments, analyze data, and draw meaningful conclusions.

Skills & Competencies

• Analytical, structured problem‑solver with strong decision‑making abilities.

• Clear, confident communicator able to influence stakeholders and management.

• Able to work independently in ambiguous environments while balancing quality and business needs.

• Proven ability to mentor and support junior colleagues.

Additional Information

• Willingness to travel up to 20%.

• Valid Belgian driving license required (or equivalent).

Why Join Baxter?

• Make a direct impact on patient safety and product quality worldwide.

• Work on high‑visibility, cross‑functional R&D projects with global reach and market transforming potential.

• Grow your expertise in sterility assurance within a respected, purpose‑driven organization.

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.

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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