Qualification Engineer Pharma (m/w/d)
Core
Planning, executing, and managing qualification activities for process equipment and utility systems in a pharmaceutical production environment.
Role type
Senior IC qualification engineer (GMP)
Builds
Qualified process equipment and utility systems for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / GMP compliance
Required skills
GMP qualification, risk assessment, change control, deviation management, CAPA, documentation management, project coordination
Preferred skills
Plant qualification, media qualification, cleanroom qualification, CAD, Data Integrity, 21 CFR Part 11
Technologies
MS Office, CAD
Responsibilities
Plan, steer, and execute qualification activities for process equipment and utility systems; Conduct risk analyses and assessments with interdisciplinary teams; Create, revise, and maintain qualification documentation (DQ, IQ, OQ, PQ); Coordinate and manage external service providers; Handle change controls, deviations, and CAPA measures; Ensure compliance with GMP and quality requirements