Validation Specialist (Kaye Validator & Autoclave)

Job Description Use of Kaye Validator software and other pressure and temperature data loggers for the qualification of Autoclaves, Dry Heat Ovens, Tunnels, and/or Freezers. Specialists must be trained and qualified on the use of this thermal mapping test equipment. This position may: Execution of Autoclave protocols Perform validation of temperature controlled equipment, process equipment, utilities, and cleaning methods. Author validation plans and procedures required to ensure a robust validation program. Assess system status to ensure systems remain in a validated state. Compile and analyze validation data, prepares reports and makes recommendations for changes and/or improvements. Ensure that risk-based approach to qualification and validation to optimize system testing efforts is broadly applied. Other duties or special projects as assigned. Qualifications Bachelor degree in Engineeringor Sciences. Minimum of 3 yearsof experience required in the medical device or pharmaceutical industry. Experience and knowledge in regulations, including GMP, QSR and ISO. Hands-on experience with Kaye Validator 2000. Excellent technical writing and verbal communication skills are required. Experience developing technical documents such as: SOP's, Protocols and reports Proficiency utilizingMS Office Suite (Word, Excel and PowerPoint) is required. Fully Bilingual (Spanish & English).