CSV Engineer

Posted 28 May 2021
Salary€70.00 - €75.00 per hour
Job type Contract
DisciplineEngineering Leaders and Specialists
ContactAisling Clements

Job description

The Role

This position is a key player within the site CSV/CQV project team, and will be responsible for a number of important tasks including but not limited to:

  • Completing lab-validation activities including analytical systems qualification.
  • Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirement specifications, risk assessments, qualification protocols, requirements traceability matrices and validation reports.
  • Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
  • Perform business analysis activities.
  • Ensure that computer systems and their associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
  • Draft test cases for QC laboratory computerized system.
  • Be 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.
  • Responsible for review of the vendor validation documents, such as validation protocols and validation summary reports.
  • Participate in deviation investigation, analysis and change assessment.

The Person

  • Educated to Degree level in Engineering, Computer Sciences or related discipline.
  • At least 5 years' experience working in the Life Sciences industry.
  • Experience of Chrome and AxiChrome skids extremely beneficial.
  • Experience of PLC/Automation systems validation required.
  • 3+ years' experience working on green or brown field projects within a highly regulated GMP manufacturing operation in Pharma or Bio.
  • A strong portfolio of Lab Systemes and Equipment Validation work is required and proven skill in this area.
  • Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.

Competitive hourly rate offered for an initial 12-month contract.

To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.