Senior Validation Specialist

7 days ago


Carlow, Ireland beBeeValidation Full time €60,000 - €90,000

Valuation Engineer Position

This is an excellent opportunity to join a leading multinational in the Biopharmaceutical industry based in Carlow.

  • Design, author, review, approve and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Develop and execute change controls to ensure compliance and efficiency.
  • Resolve technical issues during study execution and engage with production, maintenance and quality representatives as needed.
  • Provide technical input into quality notifications and investigations, and perform root cause analysis of system failures.
  • Support continuous improvement through Lean Six Sigma methodologies and serve as validation representative for cross-functional projects.
  • Ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
  • Support regulatory audits and submissions as required.

Key Requirements

  • Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers, recipe development & optimisation, cleaning verification, cleanability and recovery studies.
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Exception/Deviation Management and Change Control experience.
  • Demonstratable experience of leading technical related projects.

Essential Skills

  • Knowledge of process monitoring systems, automation systems and operational intelligence & data systems within a GMP manufacturing environment.
  • Equipment and process validation expertise.
  • Familiarity with Sterile Fill-Finish processes and equipment.


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