Biopharmaceutical Validation Quality Engineer

6 days ago

Burnaby BC, Greater Vancouver Regional District, BC; British Columbia, Canada Job type: Full-time

Support biopharmaceutical quality systems through validation, qualification, and technical documentation as a Quality Engineer at STEMCELL Technologies.

This Quality Engineer role supports full project phase execution within a life science research organization. You will work across Manufacturing, Quality Control, Process Development, and Instrumentation on commissioning, qualification, validation, and hand-over. The position also includes PPQ manufacturing support and quality investigations.

Key Responsibilities:

  • Generate master plans, schedules, risk assessments, and reports
  • Support PPQ conformance lot manufacturing and increased testing
  • Perform non-conformance and CAPA investigations when needed
  • Review and coordinate validation execution documentation
  • Train employees on applicable quality standards

Requirements:

  • Bachelor's degree in Biomedical Engineering or equivalent
  • Two to six years' experience in validation work
  • Utilities, facilities, equipment, and controlled chamber experience
  • Software assurance and Continued Monitoring familiarity
  • Excellent technical report writing and document analysis abilities

Use validation documentation, PPQ support, and CAPA investigation skills to strengthen biopharmaceutical quality assurance at STEMCELL.