Risk-based validation and cGMP expertise define this Quality Engineer chance with STEMCELL Technologies in Vancouver, supporting lifecycle verification activities.
As a Quality Engineer, you will support processes, analytical methods, and equipment lifecycle verification. The work spans commissioning, qualification, validation, and project hand-over across Manufacturing, Quality Control, Process Development, and Instrumentation. You will develop project documentation and support quality assurance compliance activities.
Key Responsibilities:
Develop metrics for process effectiveness and improvement progress
Participate in PPQ conformance lot manufacturing and investigations
Prepare and coordinate validation, commissioning, and qualification documentation
Establish procedures supporting applicable regulatory compliance
Educate and coach employees on quality standards
Requirements:
Bachelor’s degree in Biomedical Engineering or equivalent
Two to six years’ validation experience
Familiarity with risk management, ISO 14971, and cGMP
Experience qualifying utilities, facilities, equipment, and software
Solid technical writing, analysis, project, and time management skills
Apply risk management, validation, and quality systems expertise to support STEMCELL Technologies’ life science research products.