Consistently applies complex analytical methods combined to scientific thinking and experimental concepts for solutions supporting data driven decision making; Creates and reviews plans, reports, SOPs, risk assessments, change controls, design controls, process specifications, sterilization process records, regulatory documents, third party documents and supplier audits related to the area of responsibility; Plans and manages own work activities of significant technical scope with minimal direction; Develops and executes new EO and irradiation sterilization validations; Maintains sterilization process validations (e.g., quarterly dose audits, annual re-validation of EO sterilization); Responds to health/regulatory authority inquiries related to sterility assurance of combination products and medical devices; Serves as SME for sterilization for New Product Development projects; Investigates and documents sterilization process non-conformances and drives corrective actions in coordination with manufacturing site quality teams; Conducts data analysis, trending, and reporting to management; Development and integration of policies and procedures (P&P); Writes technical procedures, test protocols and reports; Seeks new challenges and open to challenge status quo; Driven in personal development; Promotes knowledge transfer and sharing of best practices; Mentors and coaches junior scientists, engineers, and technicians; Documents change control activities and related risks assessments; Flexible, open to innovative ideas and strategies; This role has frequent internal and external company contacts. This includes troubleshooting and root cause analysis for issues related to sterilization processes globally; Optimizes sterilization processes to enable time and cost savings; Initiates and maintains strategic sterilization partnerships globally and relationships with key individuals of other organizations by providing technical support and co-operation with the suppliers; Analyzes problems and synthesizes solutions, exhibiting creativity, foresight, innovation, and judgment in anticipating and solving these problems.