6+ years of experience in process and/or validation engineering in the FDA regulated industry.
Experience with Cell Therapy.
Support technology transfers of launch and commercial cell therapy products
Providing strategy and execution of process validation plans.
Analyzing manufacturing data to provide support for process improvement and investigations.
Supporting process FMEAs to understand process and product risks.
Participatingin continuous improvement projects supporting commercial manufacturing site
Identifying root cause and providing impact assessments to maintain routine manufacturing operations and determine process improvements.
Minimum of a Bachelors Degree in an Engineering or Scientific field.
