About the Job
We are seeking a skilled Process Cleaning Scientist to join our team in Limerick.
This is a unique opportunity to contribute to the development and operation of a cutting-edge manufacturing facility from the ground up.
The successful candidate will support the cleaning program for process equipment and ancillary components in the biotechnology manufacturing facilities at our site.
Key Responsibilities:
* Author and own the Cleaning Validation Master Plan for the facility.
* Develop cleaning strategy in collaboration with Engineering and Quality counterparts.
* Generate cleaning validation protocols and summary reports.
* Execute cleaning validation protocols, including visual inspection and sampling.
* 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.
* Review executed cleaning batch records/documentation.
* Troubleshoot issues and optimise 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 the cleaning program.
* Complete Periodic Review Reports to ensure cleaning equipment remains in a qualified state.
Requirements:
* 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.
* 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.