TSMS- Sr. Scientist

Key Responsibilities

• Develop cleaning strategy in collaboration with Engineering and Quality counterparts for Lilly Limerick Monoclonal Facility
• Author and own the Cleaning Validation Master Plan for the facility
• Generate cleaning validation protocols and summary reports
• Execute cleaning validation protocols, including visual inspection and sampling and coordination with other support groups (e.g. operations, maintenance, lab, etc.)
• Author cleaning procedures and associated work instructions for all equipment
• Develop cleaning batch records or appropriate documents to enable execution of cleaning activities on the production floor
• Complete review of executed cleaning batch records/documentation
• Troubleshoot issues with and optimize cleaning cycles and/or cleaning equipment
• Provide technical support on cleaning deviations/events and assist in root cause analysis.
• Completes changes associated with cleaning equipment, cleaning cycles and cleaning program.
• Completes Periodic Review Reports for key components to ensure cleaning equipment remains in a qualified state

Basic Requirements

• BS in Biochemistry, Biotechnology, Chemical Engineering or related discipline
• A minimum of 3 years of experience within the biopharmaceutical or GMP industry

Additional Preferences

• MS in Biochemistry, Biotechnology, Chemical Engineering or related discipline
• Technical knowledge of cleaning equipment (CIP skids, Parts washers, etc.) and cleaning regimes (chemical, re-circulated washing, etc.)
• Knowledge of qualification/validation requirements and good documentation practices
• Knowledge of biologics manufacturing processes and understanding of production schedules
• Strong written and verbal communication skills
• Ability to work on own initiative and as part process team consisting of a diverse group of management, production/science and engineering professionals
• Demonstrated technical capability with high productivity
• Demonstrated strong interpersonal skills
• Demonstrated adaptability and flexibility to working in different environments and teams

Work Environment

This is an 8-hour day role. As a manufacturing support function, the need for occasional evening or weekend support can arise.