Validation Engineer

PSC Biotech

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profile Job Location:

Singapore - Singapore

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

Job Summary

  • RQ of Utilities (WFI)
  • Process RQs (SIP Bulk Sterilization Autoclave)
  • Cleaning validation
  • Warehouse mapping
  • Filtration skids
  • Mixing tank
  • Washer qualification
  • Trending of Results
  • Data mining
  • LIMS queries
  • Develop review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies standards procedures and guidelines and completed in a timely fashion.
  • Lead project validation activities and provide basic guidance and direction to junior project engineer as required.
  • Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
  • Manage qualification execution and lead validation deviation investigation encountered in qualification
  • Collaborate with multi functions to arrange plan and ensure smooth running of the qualification activities.
  • Able to manage cross function stakeholders and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities.
  • Participate in site Validation Maintenance Program.
  • Support Change Implementation on site.
  • Any other tasks as and when assigned by Supervisor or Project Lead.


Requirements

  • Preferably 10 years and above of experience for a senior role
  • 3-5 years of experience in mid-level role
  • 0-3 years of experience in a junior role


RQ of Utilities (WFI)Process RQs (SIP Bulk Sterilization Autoclave)Cleaning validationWarehouse mappingFiltration skidsMixing tankWasher qualificationTrending of ResultsData miningLIMS queriesDevelop review and/or approve validation lifecycle document and protocols/reports in accordance with relevan...
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Company Industry

IT Services and IT Consulting

Key Skills

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