Biopharmaceutical Validation Quality Engineer
22 hours ago
Canada
Job type:
Full-time
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Support biopharmaceutical quality systems through validation, qualification, and technical documentation as a Quality Engineer at STEMCELL Technologies.
This Quality Engineer role supports full project phase execution within a life science research organization. You will work across Manufacturing, Quality Control, Process Development, and Instrumentation on commissioning, qualification, validation, and hand-over. The position also includes PPQ manufacturing support and quality investigations.
Key Responsibilities
Generate master plans, schedules, risk assessments, and reportsSupport PPQ conformance lot manufacturing and increased testingPerform non-conformance and CAPA investigations when neededReview and coordinate validation execution documentationTrain employees on applicable quality standardsRequirements:
Bachelor’s degree in Biomedical Engineering or equivalentTwo to six years’ experience in validation workUtilities, facilities, equipment, and controlled chamber experienceSoftware assurance and Continued Monitoring familiarityExcellent technical report writing and document analysis abilitiesUse validation documentation, PPQ support, and CAPA investigation skills to strengthen biopharmaceutical quality assurance at STEMCELL.
This Quality Engineer role supports full project phase execution within a life science research organization. You will work across Manufacturing, Quality Control, Process Development, and Instrumentation on commissioning, qualification, validation, and hand-over. The position also includes PPQ manufacturing support and quality investigations.
Key Responsibilities
Generate master plans, schedules, risk assessments, and reportsSupport PPQ conformance lot manufacturing and increased testingPerform non-conformance and CAPA investigations when neededReview and coordinate validation execution documentationTrain employees on applicable quality standardsRequirements:
Bachelor’s degree in Biomedical Engineering or equivalentTwo to six years’ experience in validation workUtilities, facilities, equipment, and controlled chamber experienceSoftware assurance and Continued Monitoring familiarityExcellent technical report writing and document analysis abilitiesUse validation documentation, PPQ support, and CAPA investigation skills to strengthen biopharmaceutical quality assurance at STEMCELL.