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 compliant biopharmaceutical manufacturing.
Role type
Equipment Validation Specialist (Level III)
Builds
Validated state of manufacturing equipment and systems for biopharmaceutical clients
Domain
Biopharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP equipment validation, Installation Qualification (IQ), Steam-In-Place (SIP), Autoclave validation, Clean Utilities validation, Shipping Validation, Temperature Mapping, Change control assessments, Validation protocol development, Quality Risk Assessments, Root cause analysis, Document Management System (DMS), Laboratory Information Management System (LIMS), Trackwise system
Preferred skills
Bachelor's degree, 2+ years experience in Manufacturing processes, QC or Environmental Monitoring, Technical writing, SOP review and approval
Technologies
DMS, LIMS, Trackwise
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, Provide technical expertise when reviewing and approving SOPs, protocols, change controls, and deviations
Seniority
Mid-level, hands-on IC
