Manufacturing Process Expert - 11 Month Contract + Possible Extensions
This is a fantastic opportunity to work on state-of-the-art fill-finish facilities and contribute to the development of commercial and process simulation qualification/validation documentation and studies.
Key Responsibilities:
* Design, author, review, approve, and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
* Provide technical input into quality notifications by authoring/reviewing/approving Process Simulation related investigations.
* Develop and execute commercial and process simulation qualification/validation documentation and studies in line with standard approval processes.
* Perform data analysis and make informed decisions/recommendations based on conclusions reached from data analysis.
* Support continuous improvement through Lean Six Sigma methodologies.
* Lead and participate in projects, system failure investigations, and investigation reports.
* Implement corrective actions through the change management system.
* Represent the company at global technical forums in relation to process simulations.
Requirements:
* Bachelor's degree or higher preferred, ideally in a science, engineering, or technical discipline.
* Knowledge of regulatory/code requirements for Irish, European, and International codes, standards, and practices.
* Report, standards, policy writing skills required.
* Equipment and process validation experience.
* Sterile filling processes and equipment knowledge.
* Proficiency in Microsoft Office and job-related computer applications.
* Lean Six Sigma methodology experience desired.
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