Automation Validation Specialist

4 days ago


Reston, Virginia, United States Tek Support Full time
Automation Validation Engineer

We are seeking an experienced Automation Validation Engineer to join our team at Tek Support in Arizona. The successful candidate will be responsible for validating automation systems, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.

Key Responsibilities:
  • Validate automation systems, including MES, SCADA, PLC, and HMI
  • Develop and execute validation protocols, test scripts, and reports
  • Ensure compliance with FDA regulations, GAMP, and industry standards
  • Collaborate with manufacturing, quality, and engineering teams
  • Analyze and troubleshoot automation system issues
  • Develop and maintain validation documentation
Requirements:
  • 5+ years of experience in automation validation, preferably in the medical device industry
  • Strong knowledge of MES, SCADA, PLC, and HMI systems
  • Experience with validation protocols, test scripts, and regulatory requirements (FDA, GAMP)
  • Bachelor's degree in Electrical Engineering, Computer Science, or related field
  • Excellent analytical, problem-solving, and communication skills
Nice to Have:
  • Experience with medical device manufacturing and quality systems
  • Familiarity with ISO 13485 and 21 CFR Part 11
  • Certification in automation validation or related field


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