Sr. IT Infrastructure Qualifications/Validation Consultant

Location: Raleigh, NC

Job Description

We are seeking a Sr . IT Infrastructure Qualifications/Validation Consultant to work onsite at our client location.  You will work on qualification of infrastructure tools for asset management, Network/Data Center component monitoring and diagramming, backup/restore and other tools used to maintain, monitor and report on qualified infrastructure.  This includes data migrations (legacy to new systems), middleware and other infrastructure components used to run the enterprise, as well as, qualification of the migration infrastructure from on-site data centers to the cloud. 

Essential Duties and Responsibilities

  • Analyze and Define infrastructure including hardware, software, network resources and services required for the existence, operation and management of a validated enterprise IT environment.
  • Develop and review processes, SOPs, Policies/Standards and other documentation for infrastructure qualifications.
  • Advise/assist Staff with the development & execution of Infrastructure Qualification processes


  • Technical degree/10+ yrs exp. in the Life Sciences Industry (Medical device, pharma/biotech, clinical)
  • Significant experience working with Quality Management Systems (QMS) and a proven track record in Validation and Qualification of IT Infrastructure   
  • Proven experience with regulatory guidelines & insuring compliance (FDA/GAMP/CFR Part 11)
  • Outstanding communication, analytic, project management and organizational skills 
  • Ability to effectively work independently in a deadline driven team environment
  • Demonstrated technical competence through serving as a Lead/Advisory resource