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Validation Specialist

1 week ago

The Municipal District of Carlow, Ireland Headcount Solutions Full time
Job Description:

We are seeking a highly skilled Senior Validation Engineer to join our team at Headcount Solutions.

This role will support Cleaning Validation including Recovery/Cleanability studies, and the successful candidate will be responsible for designing, authoring, reviewing, approving, and executing qualification/validation documentation and cycle development studies in line with standard approval processes.

Main Responsibilities:

  • Design and execute qualification/validation documentation and cycle development studies
  • Author and review execution/development of change controls
  • Resolve technical issues encountered during study execution
  • Engage with Production, Maintenance, and Quality representatives in assigned areas of operations during execution of 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
  • Drive compliance of Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in performance of day-to-day activities and all applicable job functions, ensuring consideration of impact on GMP and compliance and decisions made
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any issues around compliance