Process Validation Engineer (m/f/d)

Vernetzen, Stärken, Entwickeln und Begeistern

• das sind die Werte, die uns antreiben und die BMI zu einem Unternehmen machen, in dem Sie sich entfalten und wachsen können.

Your Key Responsibilities

• Protocol Execution: Design, write, and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for continuous extrusion and bitumen production lines.
• Process Optimization: Establish and validate Critical Process Parameters (CPPs) to guarantee consistent product properties (e.g., thickness, tensile strength, seam integrity).
• Data & Statistical Analysis: Evaluate manufacturing data using software like Minitab or JMP to assess process capability, determine operational windows, and conduct Design of Experiments (DOE).
• Problem Solving & Quality Assurance: Drive Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA) for any out-of-specification deviations.
• Change Management: Manage Engineering Change Orders to ensure any modifications to machinery or formulations are properly re-validated.
• Cross-Functional Teamwork: Partner with R&D, Maintenance, Continuous Improvement, and Production teams to transfer new formulations from pilot phases to full-scale production.
• Documentation: Draft clear technical protocols, summaries, and Standard Operating Procedures (SOPs).

Your Profile Education: Bachelor, Master, or Ph.D. in Chemical Engineering, Polymer Science, Materials Science, Mechanical Engineering, or a related discipline.

Professional Experience: 3–5+ years of process engineering or validation experience in a continuous manufacturing environment 10+y.

Industry Focus: Strong preference for backgrounds in plastics extrusion, polymer film processing, calendering, or flexible web-handling systems.

Technical Knowledge: Deep understanding of film/foil production, coating processes, and standard processing equipment (extruders, calendars, mixers).

Methods & Tools: Proven proficiency in IQ/OQ/PQ methodologies, structured problem-solving (5-Why, Fishbone, 8D), and statistical process control (SPC) software.

Advantageous Skills: Lean/Six Sigma (Black or Green Belt) qualification, knowledge of AI-based tools, thermoplastics extrusion, and bitumen processing. Experience in quality systems.

Soft Skills: Strong ability to communicate complex technical data across different departments, from machine operators to plant management.

Languages: Fluent in English; German language skills are a plus.

*Eine Karriere bei BMI ist mehr als nur ein Job! Wir helfen Ihnen, eine Tätigkeit zu finden, die Ihnen Spaß macht und in der sie Ihre Fähigkeiten nutzen und weiterentwickeln können.

Wenn wir zusammenarbeiten, können wir Großes erreichen. Schließen Sie sich uns an!*