Senior Specialist, QC Support, Cell Therapy
Core
Manage the lifecycle activities of QC laboratory equipment, including validation, maintenance, calibration, and troubleshooting to support cell therapy manufacturing.
Role type
Senior Specialist, QC Equipment Lifecycle Management
Builds
Validated and compliant QC laboratory equipment infrastructure for cell therapy production
Domain
Biopharmaceuticals / Cell Therapy / Quality Control
Required skills
cGMP compliance, equipment qualification and validation, technical writing, problem-solving, data integrity principles, GMP documentation review, change management, CAPA handling
Preferred skills
Advanced degree in science, SAP/Maximo/Valgenesis proficiency, data integrity expertise, mentorship capabilities
Technologies
SAP, Valgenesis, Maximo
Responsibilities
Create equipment User Requirements and validation protocols; Schedule and facilitate qualification, calibration, and maintenance; Maintain equipment records and databases; Perform troubleshooting and continuous improvement; Train and mentor staff on lifecycle processes
Seniority
Senior, hands-on IC