Process Validation Engineer (m/f/d)
Core
Design, write, and execute IQ/OQ/PQ protocols for continuous extrusion and bitumen production lines to validate Critical Process Parameters and ensure consistent product properties.
Role type
Process Validation Engineer
Builds
Continuous extrusion and bitumen production lines
Domain
Plastics extrusion, polymer film processing, bitumen processing
Required skills
IQ/OQ/PQ methodologies, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), Design of Experiments (DOE), Statistical Process Control (SPC), Engineering Change Order management, Standard Operating Procedures (SOP) drafting
Preferred skills
Lean/Six Sigma (Black or Green Belt), AI-based tools, thermoplastics extrusion, bitumen processing, quality systems
Technologies
Minitab, JMP
Responsibilities
Design and execute IQ/OQ/PQ protocols, Establish and validate Critical Process Parameters, Evaluate manufacturing data using statistical software, Drive Root Cause Analysis and implement CAPA, Manage Engineering Change Orders, Partner with R&D and Production teams, Draft technical protocols and SOPs
Seniority
Mid-level, hands-on IC