Equipment Validation Specialist, Level III
Core
Ensures critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines to support biopharmaceutical manufacturing.
Role type
Senior IC equipment validation specialist
Builds
Validated manufacturing equipment and systems for biopharmaceutical clients
Domain
Biopharmaceutical manufacturing / Quality Assurance
Required skills
GMP equipment validation, change control assessments, validation protocol development, root cause analysis, quality risk assessments, technical writing, DMS/LIMS/Trackwise systems
Preferred skills
Bachelor's degree, 2+ years in manufacturing processes/QC/Environmental Monitoring, understanding of IQ/SIP/Autoclaves/Clean Utilities/Shipping Validation/Temperature Mapping
Technologies
Document Management System (DMS), Laboratory Information Management System (LIMS), Trackwise system
Responsibilities
Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities; Schedule own tasks and tasks for Level 1 and Level 2 Specialists; Perform change control assessments for GMP equipment; Program, organize, and maintain Validation equipment and supplies; Develop validation protocols from Validation plans and engineering documents; Review and approve SOPs, protocols, change controls, and deviations; Perform assigned Quality Systems activities including DMS, LIMS, and Trackwise system management.