Risk-Based Validation Quality Engineer

Risk-based validation and cGMP expertise define this Quality Engineer opportunity 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
• Strong technical writing, analysis, project, and time management skills

Apply risk management, validation, and quality systems expertise to support STEMCELL Technologies’ life science research products.