Validation Engineer I
Core
Perform qualification activities (IQ, OQ, PQ) for manufacturing facilities, utilities, equipment, and instruments in cGMP environments.
Role type
Validation Engineer I
Builds
Qualified manufacturing suites and GxP-compliant equipment for advanced therapy production
Domain
Biotechnology / Cell & Gene Therapy / cGMP Manufacturing
Required skills
cGMP validation protocols, GxP compliance, risk assessment, system impact assessment, engineering lifecycle documentation, change control management, technical writing, Kneat validation systems, ASTM E2500 standards
Preferred skills
Viral vector & Cell/Gene Therapies experience, upstream/downstream purification knowledge, Kneat system proficiency
Technologies
Kneat
Responsibilities
Generate validation protocols and reports for GxP assets, perform system impact and risk assessments, support technical transfer and capital projects, maintain Validation Master Plan and SOPs, execute change controls, ensure compliance with cGMP regulations
Seniority
Mid-level, hands-on IC