CSV Engineer

  • Waterford
  • Quanta Part Of Qcs Staffing

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 systemsWork 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! #LI-TE1