Demo

Validation Engineer

cGxPServe
Springfield, TN Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/9/2025

Job summary :

Seeking a Facilities Validation Specialist who will be responsible for working across two stateoftheart medical device facilities. They will have a longterm contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities.

Responsibilities :

  • Lead facility commissioning activities across multiple sites.
  • Conduct temperature and humidity mapping studies.
  • Perform cleanroom validation for Class 6 7 and 8 environments.
  • Execute validation protocols for Class 9 cleanroom facilities.
  • Manage warehouse validation projects.
  • Develop and review validation documentation.
  • Coordinate with crossfunctional teams to ensure compliance.
  • Implement and maintain validation strategies.
  • Monitor and report on validation activities.
  • Troubleshoot and resolve validationrelated issues.

Requirements :

  • Bachelors degree in engineering Science or related field preferred.
  • 5 years of facilities validation experience in medical device or related regulated industry.
  • Proven experience with cleanroom validation and environmental monitoring.
  • Strong knowledge of GMP requirements and regulatory standards.
  • Demonstrated ability to work independently with minimal supervision.
  • Key Skills

    Python,SOC,Debugging,C / C ,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

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