Validation Expert for Sterile Fill Finish Processes

3 days ago


The Municipal District of Carlow, Ireland Life Science Recruitment Full time

In this role, you will be responsible for supporting various aspects of validation, including Sterilization, cleaning, isolators, CTU, filter and Container closure validation.

The ideal candidate will have significant experience in validation of sterile fill finish processes and equipment, as well as a relevant degree.

Key duties include:

  • Developing, implementing and maintaining qualification/validation documentation and cycle development studies in line with company standards.
  • Coordinating and executing Execution/development of change controls, including design, implementation, testing and validation.
  • Investigating and resolving technical issues encountered during study execution, including identifying root causes and developing corrective actions.
  • Collaborating with Production, Maintenance and Quality representatives to ensure smooth execution of Cycle Development & Performance Qualification activities.
  • Providing technical input into quality notifications by authoring/reviewing/approving investigations, including risk assessments and corrective actions.
  • Analyzing system failures and substandard performance to resolve machine and system issues, including developing and implementing corrective actions.
  • Contributing to continuous improvement initiatives through Lean Six Sigma methodologies, including process improvements and cost savings.
  • Representing the validation team at global technical forums and serving as a validation representative for cross-functional projects, including project management and coordination.
  • Ensuring compliance with Global Policies, Procedures and Guidelines, regulatory requirements and cGMP principles in day-to-day activities and job functions, including training and awareness programs.
  • Managing compliance via documentation completion, risk assessments, corrective actions, audits and inspections, and highlighting issues around compliance, including developing and implementing corrective actions.
  • Supporting regulatory audits and submissions as necessary, including preparing and submitting documentation.


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