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Validation Engineer

A leading bio-pharma organisation currently has a number of opportunities available for experienced validation engineers to join their team in their Carlow facility. These roles will be on initial 11-month contracts with great scope for extension/permanency.

Role Responsibilities:

  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.

  • Provide technical input into quality notification by authoring/reviewing/approving investigations.

  • Execution of equipment commissioning and qualification programs.

  • Execution of equipment/qualification validation programs; including re-qualification and revalidation.

  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.

  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.

  • Lead/Plan C&Q, validation activities as required

Role Requirements:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline

  • 3-5 Years experience working in a similar role/GMP environment

  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices

  • Report, standards, policy writing skills required

  • Equipment and process validation

  • Sterile filling processes and equipment

  • Proficiency in Microsoft Office and job-related computer applications required

  • Lean Six Sigma Methodology experience desired

For a confidential discussion and more information on the role, please contact Barry O'Brien