Qualifizierungsingenieur / Qualifizierungstechniker (m/w/d), Binzen
Core
Support German pharma customers with GMP-compliant initial and re-qualification of production plants, rooms, utility systems, and software systems for drug manufacturing.
Role type
Senior IC qualification engineer/technician
Builds
Qualification plans, qualification reports, and GMP-compliant documentation for pharmaceutical production systems
Domain
Life Sciences (Pharma/BioTech/MedTech) + Engineering/Validation
Required skills
GMP compliance, risk assessment, qualification planning, documentation, project coordination, technical engineering
Preferred skills
Quality Assurance experience, risk-based thinking, audit preparation
Technologies
GMP, CSV, automation systems, software validation tools
Responsibilities
Conduct risk assessments, create qualification plans, execute qualification activities, document GMP-compliantly, summarize results in qualification reports, collaborate with project managers, prepare for regulatory inspections and customer audits
Seniority
Mid-Senior, hands-on IC
