Validation Engineer
Core
Lead commissioning, qualification, and validation activities for packaging and combination product assembly lines to ensure compliance with GMP, data integrity, and regulatory expectations.
Role type
Senior Validation Engineer
Builds
Operational readiness for FDA-regulated life sciences and mission-critical industries
Domain
Life Sciences / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, validation protocol development, FAT/SAT execution, CAPA management, risk mitigation, vendor coordination, cross-functional collaboration
Preferred skills
Design input, documentation creation and review
Technologies
None stated
Responsibilities
Lead end-to-end validation activities in a GMP environment, plan and execute qualifications, oversee FAT/SAT and commissioning activities, manage deviations/CAPAs, partner with Engineering/Operations/QA/IT teams to troubleshoot issues
Seniority
Senior, hands-on IC
