Cleaning Validation Professional
6 days ago
About Cpl Healthcare
Cpl Healthcare is a leading provider of healthcare professionals and managed services, dedicated to advancing healthcare by bringing life-changing medicines to patients worldwide.
Our biopharma client based in Limerick is committed to excellence in manufacturing, with a state-of-the-art Biotech Drug Substance Manufacturing Facility designed to meet the highest standards of quality and safety.
This is an exceptional opportunity to join a dynamic team and contribute to the development and operation of this cutting-edge manufacturing facility.
Main Responsibilities
The Process Cleaning Scientist will be responsible for:
- Supporting the cleaning program for process equipment and ancillary components in the biotechnology manufacturing facilities at our biopharma client in Limerick.
- Authoring and owning the Cleaning Validation Master Plan for the facility.
- Developing cleaning strategy in collaboration with Engineering and Quality counterparts for the Limerick Monoclonal Facility.
- Generating cleaning validation protocols and summary reports.
- Executing cleaning validation protocols, including visual inspection and sampling, and coordinating with other support groups (e.g., operations, maintenance, lab).
Skills and Qualifications
The successful candidate will have:
- 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.
- 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.
- Understanding of biotech manufacturing processes and production schedules.
- Strong written and verbal communication skills.
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