IT Validation Area Specialist

  • Category
    Engineering
  • Location
    Raleigh, North Carolina
  • Type
    Direct hire

We are looking for an IT Validation Area Specialist to provide and lead validation services required for the successful delivery of the IT & Automation Projects. You will also provide validation & technical support through the preparation, execution, data analysis, & report writing for IQ, OQ & PQ protocols. Additionally you will:

  • Perform compliance & technical reviews/approvals of protocols & protocol data
  • Create new & modify existing validation procedures as required
  • Lead validation failure investigations & non-conformities utilizing root cause analysis techniques
  • Create & modify existing configuration item lists (CIL’s) as required
  • Review & approve specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes
  • Participate in FAT, SAT, commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment, system or process
  • Identify process improvements before equipment, systems or processes are placed under change control during validation
  • Manage the budget oversight as needed.
  • Supervise the contractor scheduling & oversight as needed. 

To be successful as a IT Validation Area Specialist you will need:

  • BS in Engineering, Computer Science, or applicable technical degree.
  • 5+ years validation or quality related discipline experience in pharmaceutical environment
  • Expert in quality concepts including technical & compliance review of documents, expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation)
  • Expert in cGMP documentation practices
  • Requires a minimum of 2 years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation
  • Ability to independently write protocols & technical documents without supervision. Knowledge of statistical methods
  • Expert knowledge of cGMP documentation practices required
  • Experience in validation test equipment including temperature mapping equipment, Kaye equipment as an example, desired


 

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