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Engineering Validation Professional

3 weeks ago

Portlaoise, Laois, Ireland Asset Recruitment Full time
About the Role:

We are seeking a Senior Validation Engineer to join our team at a leading pharmaceutical manufacturer in Carlow. This is a contract role, working on behalf of our client, Asset Recruitment. The successful candidate will be responsible for ensuring that all equipment and processes meet the highest standards of quality and regulatory compliance.

The ideal candidate will have a strong technical background in engineering or a related field, with a proven track record in delivering excellence. Key responsibilities will include project validation support, authoring project validation master plans, SOP and documentation updates, resolving technical issues, and executing validation studies.

Key Responsibilities:

  • Design/Author/Review/Approve/Execute development of change controls and qualification/validation of documentation and cycle development studies
  • Serve as validation representative for cross-functional projects and represent the validation team at global technical forums
  • Resolve technical issues encountered during study execution
  • Engage with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues

Requirements:

  • Engineering or scientific background
  • Strong technical writing and oral communication skills
  • Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers
  • Leadership experience in technical projects
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification