Autoclave Validation Engineer

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profile Job Location:

Johns Creek, GA - USA

profile Monthly Salary: Not Disclosed
Posted on: 4 hours ago
Vacancies: 1 Vacancy

Job Summary

Position: Autoclave Validation Engineer
Work Location: Johns Creek GA 30092
Pay rate: $60K - 115K/annum
Duration: Full-Time
Job Description:
  • Develop PQ protocols using templates available in Kneat.
  • Update Templates as needed for process improvements related to reduced MPQ processes.
  • Submit protocols for approval
  • Execute all test functions as defined in the protocol
  • Collect review and analyze test data
  • Document and resolve any deviations encountered
Each PQ protocol shall include but not limited to:
  • Test Instrument Calibration Verification
  • Biological Indicator Preparation
  • Biological Challenge (Max Load Sterilization Efficacy)
  • Empty Chamber Temperature Distribution
  • Requalification Review (Maintenance Change Control Logbook Review Software version review)
Qualification:
BS/MS in Biotechnology/Industrial Biotechnology/Industrial Engineering/Mechanical Engineering with 10 yrs of equipment validation experience in Pharma/MedTech environments
Position: Autoclave Validation Engineer Work Location: Johns Creek GA 30092 Pay rate: $60K - 115K/annum Duration: Full-Time Job Description: Develop PQ protocols using templates available in Kneat. Update Templates as needed for process improvements related to reduced MPQ processes. Submit ...
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Key Skills

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