About the Role
Our biopharma client based in Limerick is dedicated to advancing healthcare by bringing life-changing medicines to patients worldwide. Their state-of-the-art Biotech Drug Substance Manufacturing Facility in Limerick is designed to be one of the most technically advanced manufacturing sites in the industry, utilizing next-gen technologies and advanced data platforms to enhance safety, quality, and productivity.
Main Purpose and Objectives of the Position
The Process Cleaning Scientist will support the cleaning program for process equipment and ancillary components in the biotechnology manufacturing facilities at our biopharma client in Limerick.
Key Responsibilities:
1. Author and own the Cleaning Validation Master Plan for the facility.
2. Develop cleaning strategy in collaboration with Engineering and Quality counterparts for the Limerick Monoclonal Facility.
3. Generate cleaning validation protocols and summary reports.
5. Develop cleaning batch records or appropriate documents to enable execution of cleaning activities on the production floor.
6. Review executed cleaning batch records/documentation.
7. Troubleshoot issues and optimize cleaning cycles and/or cleaning equipment.
8. Provide technical support on cleaning deviations/events and assist in root cause analysis.
9. Complete changes associated with cleaning equipment, cleaning cycles, and the cleaning program.
10. Complete Periodic Review Reports to ensure cleaning equipment remains in a qualified state
Additional Skills/Preferences:
* Technical knowledge of cleaning equipment (CIP skids, parts washers) and cleaning regimes (chemical, re-circulated washing).
* 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 independently and as part of a process team, including management, production/science, and engineering professionals.
* Flexibility to respond quickly and proactively to changing priorities within a limited timeline.
Educational Requirements
BSc (Hons) in Engineering or Science with 2 years of similar experience supporting the cleaning program for process equipment and ancillary components in a pharmaceutical/biopharmaceutical manufacturing site