Qualifizierungsingenieur/in (m/w/d) – Anlagen, Equipment & Utilities
Core
Support Engineering Leadership in planning, executing, and developing GMP-compliant qualification of production plants, equipment, rooms, and utility systems.
Role type
Junior-to-mid level GMP qualification engineer (plant & utilities)
Builds
GMP-compliant production facilities and utility systems for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / GMP engineering
Required skills
GMP qualification phases (DQ, FAT, SAT, IQ, OQ), technical understanding of production plants and utilities, P&ID and technical drawing interpretation, structured documentation, change control and CAPA support
Preferred skills
1-2 years experience in plant qualification or commissioning, supplier site visits, cross-functional project management
Technologies
GMP documentation standards, P&IDs, technical drawings, manufacturer documentation
Responsibilities
Plan, execute, and document qualifications for production plants, equipment, rooms, and utilities; track punch lists and test deviations; support change controls and CAPAs; collaborate with Engineering, Production, QA, and external suppliers
Seniority
Junior, hands-on IC with mentorship
