Principal Engineer, Sterility Assurance

As a Principal Engineer at Baxter, you will provide Sterility Assurance leadership and technical support to multi-disciplinary product development teams, domestic/international manufacturing facilities, Regulatory Affairs and internal Sterility Assurance customers. You will act as the Sterility Assurance Project Lead (Focal Point) for new product development, sustaining product support, and manufacturing facility MIP initiatives. What you'll be doing: Coordinate, prioritize, and manage multiple Sterility Assurance-related activities with minimal guidance. Provide input for schedules, budget, product requirements, and design. Provide support for regulatory submissions. Liaise with cross-functional project teams and manufacturing facilities to develop validation plan (i.e. Rationale Statement) and sterilization parameters for product development. Lead and support product development studies. Lead agile Sterility Assurance internal project meetings. Effectively communicate program status to multi-disciplinary project team members, management, key stakeholders. Provide support for complex investigations, troubleshooting, and CAPAs. Evaluate data/results relative to product requirements, definitions and/or program goals.