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CSV Engineer

  1. Midlands (Ireland)
Waterford
  1. Contract
Competitive
  1. CAPEX Projects
12-04-2024
TE33412
CSV Engineer - Pharmaceuticals - 12 -Month Contract - Waterford

Our Partner in Waterford develop and supply innovative pharmaceutical products to customers globally. They are undergoing several site upgrades, and require a CSV Engineer to help support projects on a contract basis.

Key responsibilities as a CSV Engineer:
  • Partner with local project teams to deliver Automation and IT aspects of capital projects.
  • Liaise with site AIT group to add input to site SOP’s.
  • AuthorReviewApproval of qualification lifecycle documents for processlab systems
  • Work with site teams on generation of requirement andor configuration specification, design specifications and test protocol generation, execution and approval.
  • Maintain Inventory and control upgrades to DELTA-V/OEM automation systems.
  • Generate any automation change control documentation required for introducing new systems or modifying existing systems.
  • Generate any risk assessmentvariance documentation and interface with above site team to close out same.
  • Interface with above site teams for deliverables of Enterprise systems as required.
  • Ensures that SDLC is appropriately applied.

Experience required as a CSV Engineer:
  • BS in Engineering, Computer Science, or other technical degree.
  • 3 or more years of experience in project/automation/IT support in a similar role.
  • Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines 
  • Excellent facilitation, problem solving, and decision-making skills.
  • Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles
  •  identify appropriate process and technological solutions is essential.
  • Experience in Delta-V & OEM Automation systems.

If this CSV Engineer role is of interest to you, please apply now! 

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