Process Expert (m/f/d)
Core
Ensure safe, efficient, and compliant manufacture of high-quality drug substances through equipment qualification, cleanroom management, and deviation handling.
Role type
Process Expert (SME) in pharmaceutical manufacturing
Builds
High-quality drug substances for Novartis
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
Equipment qualification, cleanroom management, deviation handling, GMP documentation, change request management, regulatory inspection support, stakeholder collaboration, continuous improvement
Preferred skills
Pharmaceutical industry experience, automation affinity, self-driven project ownership
Technologies
GMP systems, cleanroom management tools
Responsibilities
Coordinate equipment qualification and cleanroom activities, manage service provider administration for cleaning and gowning, handle deviations and implement change requests, create and maintain lifecycle documents, represent the company during Health Authority inspections, collaborate on improvement projects
Seniority
Mid-level, hands-on IC
