Validation Engineer

  • Reference: GY46618
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

My client, a Pharmaceutical company located in Co. Galway, is looking for a Validation Engineer.

Main responsibilities:

  • Responsible for writing, executing & reporting of all validation activities including but not limited to (VP/ DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).

  • Validation/Qualification projects will be across a range of production areas which may include, Equipment Qualification (Lyophilisers, Autoclaves, Filling Lines etc), Product Processes, Cleaning, Computerised Systems, Utilities and associated Capital projects.

  • Act as a subject matter expert in process validation which will be performed against Corporate SOP/HPRA /FDA/EMEA requirements.

  • Generation, execution and close out of validation projects relating to existing products and new product introductions.

  • Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation.

  • Statistical analysis of data to determine process capability.

  • Execution and documenting of process risk assessment / failure mode and effects analysis.

  • Track and resolve exceptions during qualification activities.

  • Represent validation at internal and external audit.

For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email edyta.fleming@collinsmcnicholas.ie.


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Edyta Fleming

Contact Consultant

  • Edyta Fleming
  • Recruitment Consultant
  • 091 706721
  • Connect with Edyta

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