CQV Engineer

Bellevue, NE, US • Posted 11 days ago • Updated 10 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Process Flow
  • Functional Design
  • Testing
  • SIP
  • Collaboration
  • Manufacturing Engineering
  • IQ
  • OQ
  • Mapping
  • Business Intelligence
  • Training
  • Quality Control
  • Reporting
  • Documentation
  • Cell Culture
  • Harvest
  • Chromatography
  • GDP
  • Computerized System Validation
  • FOCUS

Summary

Responsibilities:
  • CQV resources supporting an NPD large-cap project modifying existing equipment and processes for future methods in an existing large-scale cell culture facility.
  • Focus on process equipment on the floor, walking systems down, and executing qualifications and related documentation.
  • ll validation documentation and execution in ValGenesis (e-validation platform), including one documentation-focused resource.

Most Important Skills Needed:
  • Strong CQV experience with process equipment; able to work independently, set their own pace and goals, and still maintain team structure on second shift.
  • Hands-on execution of IQ and OQ and traditional qualification activities, including:
  • Walking drawings down and verifying against field configuration.
  • TOPs for materials certifications.
  • Verifying maintenance systems are active.
  • Verifying process flow paths and operation per functional design.
  • Wet testing.
  • SIP/CIP cycle development for flow paths in coordination with manufacturing engineering.
  • Post-IQ/OQ activities:
  • Steam-in-place temperature mapping.
  • BI (biological indicator) training and retrieval.
  • Pulling process data and working with QC lab reports.
  • Generating, executing, and reporting on validation documentation in ValGenesis.
  • Experience / comfort working with:
  • Large-scale cell culture (20kL bioreactor; batches 8-16kL).
  • Downstream equipment: harvest clarification, viral filtration, ultrafiltration, buffer transfer, tank farms, chromatography.
  • Steam clean-in-place activities.
  • Strong GDP and project timeline execution; ability to support compressed schedule with 2-3 shift coverage.
  • No CSV or lab validation required (process/CQV focus only).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: cf653e975178c790edebed2112da5f1b
  • Posted 11 days ago
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