Lead Validation Engineer II

Requirements: Bachelor’s degree in Pharmaceutical Science, Biomedical Science, Biomedical Engineering or related field and eight years of validation experience in the pharmaceutical industry. Experience must include five years each of the following: performing equipment, facilities, and utilities qualification/validation in commercial pharmaceutical cGMP MoH regulated industry; using deviation, change management, and electronic documentation management systems; Valgenesis, Veeva, Maximo, or Trackwise; temperature mapping data logging systems and software, such as Ellab, Val Probe, Kaye validator AVS or 2010, TMI-Orion, or Temptale; root cause analysis tools; wearing gowning PPE used in aseptic and non-aseptic manufacturing areas; and performing risk analysis/assessment. Experience may be gained concurrently.

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