An established global leader in the biopharmaceutical industry, are currently searching for an experienced CSV engineer to join their global manufacturing operations network with a greenfield production campus in North Leinster.

This position is a 12-month fixed term contract, which is likely to be extended as a result of a large volume of industry-critical project deliverables forecasted for the next 5 years.

The person will be the Computer Systems Quality representative in support of CSV activities executed on site. As the CSV specialist, you will be responsible for ensuring the timely review/approval of documentation at a critical business period, resolution of any internal/external quality issues relating to CSV project activities in accordance with project and site SOPs within a start-up manufacturing site.

Main responsibilities:

• Drafting of test cases for QC laboratory computerized system
• Responsible for establishing and revising of VP for QC laboratory computerized system.
• Lead risk assessment before test execution, such risk assessment includes but not limited to ERES assessment, system functional risk assessment.

Suitable candidate will have:

• Degree in Science, preferably majoring in pharmaceutical engineering, computer science, automation, software engineering and related subjects
• Minimum 3 years validation experience in Pharmaceutical industry and/or QC labs

Benefits:

• Highly competetive hourly rate
• Working with well-known global leader
• Long term 12-month contract, with strong probability of extension

For more information, email in strictest confidence Rachel Duggan at or call on 0894937334 for the latest market opportunities and information.