Lead Validation Engineer
Core
Lead validation activities for a radiopharmaceutical facility, managing commissioning, qualification, and validation (CQV) for GMP operations to support clinical development and commercial manufacturing.
Role type
Senior IC Lead Validation Engineer (GMP)
Builds
GMP-compliant radiopharmaceutical production facilities and processes
Domain
Biotechnology / Oncology / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP validation strategy, cross-functional leadership, deviation investigation, CAPA management, risk assessment, technical writing, regulatory compliance, process improvement, mentoring
Preferred skills
Prior experience leading complex validation programs, mentoring engineers, AI application for team execution
Technologies
GMP cleanroom systems, computerized systems, analytical equipment, process equipment
Responsibilities
Lead cross-functional validation programs for facility, utilities, and equipment; Develop and improve CQV strategies for GMP spaces; Manage complex validation protocols and lifecycle documentation; Lead deviation investigations and root cause analysis; Mentor validation engineers and cross-functional teams; Support regulatory inspections and audits
Seniority
Senior, hands-on IC with leadership responsibilities
