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Engineer
4 weeks ago
Contract
Thousand Oaks, California, US

Job Description

  • Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
  • Assist in development and review of User Requirements Specifications (URS).
  • Suggest design modifications to address risks and design in quality and safety.
  • Organizes, analyses and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
  • Perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.
  • Recommend, evaluate, and manage performance of contract resources
  • Provide oversight for verification deliverables developed by outsourced/contract verification staff.
  • Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
  • Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
  • Ensure safety during commissioning, validation, maintenance and manufacturing activities
  • Support Manufacturing and QA with Performance Qualification (PQ) activities.

Job Requirements

single use technologies, Inoculation, Bioreactors, Chromatography , Tangential Flow Filtration, validation processes, documentation, transfer technology

 

Job Code: 821696

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