Process Validation Engineer (m/f/d)
BMI Deutschland GmbH · Heusenstamm, Hessen ·
## 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+ years.
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.
- ## What we offer: - based on hiring location it would include a range of the following:
- Future-Proof Compensation: Attractive salary package & company pension scheme
- Work-Life-Balance: 30 days of vacation, flexible working hours & primarily office-based work with a regular mobile office option
- Diverse Mobility Solutions: Job bike (JobRad), commuting allowance & free parking
- Support for Families: Childcare cost subsidy & pme Family Service
- Focus on Further Development: Individual development and training opportunities
- Health Matters: Health benefits & BMI supplementary health insurance fund (Zuschusskasse)