12 Mar
Validation Engineer- Local to Lexington, MA
Massachusetts, Lexington , 02420 Lexington USA

Vacancy expired!

Job Role: Validation Engineer Location: Lexington, MA - Local only as consultant will need to be onsite a few days a week. Experience: 7+ Yrs Duration: 10+ Months Client is going from on premise to AWS with the Validation Systems. Job Description: At high level, requirements are:

  • Basic understanding of ellab ValSuite (or any MFG IT Validation SW)
  • Previous GxP / Pharma or Takeda exp. is preferred.
  • Experience with IQ/OQ and Validation activities
  • Documentation:
  • Validation Plan, Updates to URS, SDCS, SOPs, Training documentation, etc.
  • Authoring / Updates of Test Scripts (OQ) and
  • OQ Execution Report, Val Summary Report
  • Document deliverables per Takeda GxP SOPs
  • Validation / Qualification:
  • Dry run of OQ scripts in DEV
  • Execution of IQ/OQ in VAL as needed
  • Execution of IQ/SRT (System Readiness Test) in PROD as needed
  • Validation deliverables per Takeda GxP SOPs
  • Must Have
    • GxP Validation
    • Ellab ValSuite is their system and doing an upgrades from version X to Y
    • With the upgrade they are going from on premise to AWS
    • Need excellent documentation skills. They use Veeva
    • Team consists of 5 members
    • Paperless Validation is a huge plus. They use KNEAT (having this would be awesome)
    • Will test and qualify systems
    • Onsite in Lexington, MA and needs local consultant. Will be onsite 2 to 3 days a week

    Vacancy expired!


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