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.