Scientist - Process Cleaning
Scientist - Process Cleaning
Eli Lilly
Limerick, Ireland
The Process Cleaning Scientist will be responsible for supporting the cleaning program for process equipment and ancillary components in the Biotechnology Manufacturing Facilities at Lilly, Limerick.
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
- Trouble-shoot issues with and optimize cleaning cycles and/or cleaning equipment
- Provide technical support on cleaning deviations/events and assist in root cause analysis
- Complete changes associated with cleaning equipment, cleaning cycles and cleaning program
- Complete Periodic Review Reports for key components to ensure cleaning equipment remains in a qualified state
Additional Skills/Preferences:
- 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 Biotech 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.
- Ability to respond quickly and proactively to changing priorities within a limited timeline
- Educational Requirements: BSc (Hons) in either Engineering or Science with 2 years similar experience supporting the cleaning program for process equipment and ancillary components in a pharmaceutical/biopharmaceutical manufacturing site
- Language Requirements: Proficient in English
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