Cleaning Validation Engineer

  • Contract
  • Cork

Website TPM05137

A global biopharmaceutical company in Cork is looking to hire a Cleaning Validation Engineer. The successful candidate will be responsible for supporting the cleaning program on site.


  • Responsible for ensuring that the Manufacturing Process Transfers project tasks and cleaning tasks are completed on time.
  • Generation of Validation Impact Assessments (“VIA”).
  • Review of Change Controls.
  • Generation of Process Validation Plans.
  • Generation of Cleaning Validation Plan(s).
  • Update of Cleaning Validation and Process Validation documentation impacted by the changes.
  • Cleaning Technical Assessment.
  • Process Flow of Products/Equipment.
  • Cleaning Validation Matrix.
  • Generation of Process Performance Qualification (“PPQ”) and Process Validation (“PV”) Protocol(s).
  • Execution of Process Validation Protocol (PPQ/PV) activities.
  • Conduct training on PPQ/PV Protocols.
  • Generation of PPQ and PV Reports.
  • Review/Approval of project Failure Mode Effect Analysis (“FMEA”) /Technical Assessments as required.
  • Performance of cleaning validation as per Cleaning Validation Plan(s)/Protocol(s).
  • Any other ad hoc project deliverables.

Qualifications & Experience:

  • Minimum – BSc in either Engineering or Science
  • 5 years’ experience supporting a pharmaceutical / biopharmaceutical manufacturing site.
  • Previous experience in cleaning validation would be an advantage.
  • Knowledge of qualification/validation requirements and good documentation practices.

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