Risk-based validation expertise meets cGMP quality engineering at STEMCELL Technologies in Vancouver, supporting processes, methods, and equipment verification.
As a Quality Engineer, you will support lifecycle verification across commissioning, qualification, validation, and project hand-over activities. You will collaborate with Manufacturing, Quality Control, Process Development, and Instrumentation teams. Your work includes risk assessments, protocols, schedules, master plans, and summary reports.
Key Responsibilities:
- Develop metrics for process effectiveness and improvement progress
- Support PPQ conformance lot manufacturing and increased testing
- Perform non-conformance and CAPA investigations when needed
- Prepare and coordinate validation, commissioning, and qualification documentation
- Coach employees on applicable quality standards and procedures
Requirements:
- Bachelor's degree in Biomedical Engineering or equivalent
- Two to six years of validation experience
- Familiarity with risk management, ISO 14971, and cGMP
- Experience qualifying utilities, facilities, equipment, and controlled temperature chambers
- Strong technical report writing, analysis, project, and time management skills
Apply validation, risk management, and technical documentation expertise to quality assurance at STEMCELL Technologies in Vancouver.
Quality Engineer Validation Specialist in Burnaby employer: STICA STEMCELL Technologies Canada Inc.
STEMCELL Technologies is an exceptional employer that fosters a collaborative and innovative work culture in Burnaby, where employees are empowered to lead impactful projects in the biotech sector. With a strong commitment to employee growth, we offer continuous learning opportunities and support for professional development, ensuring that our team members thrive in their careers while contributing to meaningful advancements in science and technology.
Contact Details:
STICA STEMCELL Technologies Canada Inc. Recruitment Team
