Validation Quality Engineer cGMP

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.

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