Senior CSV Engineer - IT Labs

Posted 08 July 2021
Salary€70.00 - €75.00 per hour
LocationCounty Louth, Leinster
Job type Contract
DisciplineEngineering Leaders and Specialists
ContactAisling Clements

Job description

New Senior CSV Engineering Contract available with a leading global biologic organisation who provide comprehensive integrated and customisable services to the biopharmaceutical sector. These services include contract development and contract manufacturing across their network in Asia, Europe and the US.

Once built, this Leinster based manufacturing site will be the largest single-use biologics plant globally and has been designed to run next generation manufacturing technology, continuous bioprocessing.

This role is focused on supporting ongoing commissioning projects for an initial 12-month contract but there is approximately 2 years work available.

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.