R&D Sterility Assurance - Project Lead

• Act as the Sterility Assurance Project Lead / Focal Point for R&D programs
• Define and execute sterility assurance strategies, including test methodvalidation plans, rationale statements, and sterilization parameters
• Provide interpretation and guidance on GxP and global sterility regulations
• Support regulatory submissions related to sterility assurance
• 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)
• 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
• 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

• B.S. in Engineering with 5–8 years of experience
• M.S. with 2–4 years
• Ph.D. with 1–2 years of relevant industry experience
• 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
• 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
• Willingness to travel up to 20%
• Valid Belgian driving license required (or equivalent)

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

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer