STEMCELL Technologies seeks a Quality Engineer skilled in cGMP validation, technical documentation, and qualification across regulated life science operations.
This Quality Engineer supports processes, analytical methods, and equipment lifecycle verification within risk-based validation programs. You will create master plans, schedules, risk assessments, protocols, and summary reports. The position collaborates across Manufacturing, Quality Control, Process Development, and Instrumentation during project phase execution.
Key Responsibilities:
- Prepare master plans, schedules, risk assessments, and protocols
- Coordinate commissioning, qualification, validation, and hand-over execution
- Support PPQ manufacturing with increased testing activities
- Establish quality procedures, processes, and policies
- Train and advise employees on quality standards
Requirements:
- Bachelor's degree in Biomedical Engineering or equivalent
- Two to six years in a validation job
- Qualification experience in manufacturing and quality control laboratories
- Experience with temperature chamber mapping and monitoring
- Excellent technical report writing and document analysis abilities
Bring cGMP validation, qualification, and technical reporting experience to collaborative project execution at STEMCELL Technologies.
Validation Quality Engineer cGMP in Burnaby employer: STEMCELL Technologies Inc
STEMCELL Technologies is an exceptional employer, offering a dynamic and science-oriented work environment in Vancouver, where employees are empowered to contribute to cutting-edge life science research. With a strong commitment to inclusivity, competitive salaries, and comprehensive benefits, STEMCELL fosters meaningful career development opportunities while being recognized as one of Canada’s Best Managed Companies. Join a team of passionate professionals dedicated to making a difference in the world of biotechnology.
