Cleaning Validation Engineer - Join our team in Carlow
This 11-month hybrid role is an excellent opportunity for those with 2+ years of experience in cleaning validation in a Fill-finish environment.
About the Role:
* We are seeking a skilled Cleaning Validation Engineer to join our team in Carlow.
* The successful candidate will be responsible for designing and executing qualification/validation documentation and cycle development studies, ensuring compliance with standard approval processes.
Your Key Responsibilities:
* Author, review, approve, and execute execution/development of change controls.
* Resolve technical issues encountered during study execution.
* Engage with production, maintenance, and quality representatives in assigned operations during Cycle Development & Performance Qualification activities.
* Provide technical input into quality notifications by authoring/reviewing/approving investigations.
* Perform root cause analysis of system failures, substandard performance, using standard tools and methods to resolve machine and system issues.
* Support continuous improvement through Lean Six Sigma methodologies.
* Serve as validation representative for cross-functional projects and represent the validation team at global technical forums.
* Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in day-to-day activities and applicable job functions.
Requirements:
* Experience in cleaning validation, including CD & PQ of mobile vessels (CIP) and parts washers (COP), recipe development & optimisation, cleaning verification, cleanability, and recovery studies using TOC, ICP, & swab methods, acceptable residual limit determination, worst-case soil matrices, and strategy development.
* Considerable experience in a comparable role, operating as an individual contributor adding value to the business in a GMP manufacturing setting, along with relevant qualifications/skills.
* Exception/Deviation Management and Change Control.
* Demonstratable experience leading technical-related projects.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
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