A Scientist – Process Cleaning is required to join a leading global Biopharmaceutical business based in Limerick. This is a fantastic opportunity to join a global business focused on developing and manufacturing break through medicines. This is a fully site based role on a brand new technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance.

The Process Cleaning Scientist will be responsible for supporting the cleaning program for process equipment and ancillary components in the Biotechnology Manufacturing Facilities.

The Role

• Develop cleaning strategy in collaboration with Engineering and Quality counterparts
• 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
• 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.

• 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.

• 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