Cleanroom Validation Specialist

12 hours ago


The Municipal District of Carlow, Ireland PE Global Full time

PE Global is currently recruiting for a professional to join our team as a Cleanroom Validation Specialist. This is an exciting opportunity for an individual with experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP).

The successful candidate will be responsible for designing, authoring, reviewing, approving, and executing qualification/validation documentation and cycle development studies in line with the standard approval process.

  • Main Responsibilities:
  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Resolving technical issues encountered during study execution.
  • Engagement with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
  • Technical input into quality notification 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.
  • Serve as validation representative for cross-functional projects and represent the validation team at global technical forums.
  • Drive compliance of Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.


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