Cleaning Validation Specialist
2 weeks ago
About the Role
This is a senior validation engineer position that requires extensive experience in cleaning validation. The ideal candidate will have a strong understanding of cleaning verification, cleanability, and recovery studies using TOC, ICP, and swab methods.
Key Responsibilities:
- Design and execute qualification/validation documentation and cycle development studies in line with standard approval processes.
- Develop and implement effective change controls and resolve technical issues encountered during study execution.
- Engage with production, maintenance, and quality representatives during execution of Cycle Development & Performance Qualification activities.
Requirements:
- Relevant technical degree and 5+ years of experience in validation of sterile fill finish processes and equipment including extensive cleaning validation experience.
- Demonstrable experience of leading technical related projects.
- Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
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