(Senior) Qualification / Validation Engineer (w/m/d)
Core
Proactive expansion of the Qualification & Validation business area, executing DQ/IQ/OQ/PQ and Process/Cleaning/CSV validation activities under cGMP regulations.
Role type
Senior IC Qualification & Validation Engineer
Builds
GxP-compliant qualification and validation projects for pharmaceutical clients
Domain
Pharmaceutical industry / Quality Assurance
Required skills
cGMP compliance, GxP risk analysis, SOP creation, project coordination, consulting support, cost estimation
Preferred skills
Team leadership, client/vendor management, analytical skills
Technologies
cGMP, GxP, CSV, DQ, IQ, OQ, PQ
Responsibilities
Execute qualification and validation activities (DQ, IQ, OQ, PQ), perform GxP risk analyses, coordinate project interfaces, create GMP documents (SOPs, DQ/IQ/OQ/PPQ), support consulting tasks, estimate project costs
Seniority
Senior, hands-on IC with leadership potential
