Sterile Manufacturing Technical Expert

2 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time

About the Role

We are seeking an experienced Sterile Manufacturing Technical Expert to join our team in Carlow. As a key member of our operations team, you will be responsible for providing technical support and guidance on process simulation development and execution.

Your Key Responsibilities

  • Design and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authorizing/reviewing/approving Process Simulation related investigations.
  • Author and review qualification/validation documentation and studies in line with the standard approval process.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.

Your Requirements

  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline.
  • 3 - 5 year's operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.
  • Demonstrated ability to coach and lead change.
  • Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment.


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