Expert (m/w/d) Sterility Assurance – Sterilization Validation
Core
Responsible for fulfilling regulatory requirements for the validation of sterilization and decontamination processes at the Halle/Westfalen site, representing the department in internal and customer projects.
Role type
Expert Sterility Assurance – Sterilization Validation
Builds
Validated sterilization and decontamination processes for injectable pharmaceuticals (oncology therapeutics)
Domain
Pharmaceutical manufacturing / Oncology / Sterile Drug Production
Required skills
Sterilization and decontamination technologies, Microbiological fundamentals, Statistical data analysis, Risk management methods, Validation standards, Regulatory compliance, Change control management, Trend monitoring
Preferred skills
Experience with isolators, Regulatory intelligence, Cross-functional project leadership
Technologies
Isolation systems, Trending tools, Risk analysis frameworks
Responsibilities
Optimize validation systems according to state-of-the-art and regulatory requirements, Create and maintain validation instructions and report templates, Present validation concepts and results during audits and inspections, Provide technical support for submission documents, Author validation offers for contract manufacturing, Support production with deviations and change controls in sterilization, Create and maintain risk analyses for sterilization validation, Create and maintain trending tools for validation results, Build and maintain regulatory intelligence for sterilization validations, Participate in cross-functional projects and process optimization initiatives, Plan, coordinate, conduct, document, and evaluate (re-)validations, Create validation plans and reports, Develop loading plans for isolators and conduct training for production staff