Process Validation Engineer (m/f/d)

BMI Deutschland GmbH; Offenbach am Main; On-site; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Salary package & pension

30 days vacation & flexible hours

Job bike & parking

Childcare subsidy

Development opportunities

Health benefits

Job summary

Arbeitsagentur in Germany seeks a process engineer to design and validate IQ/OQ/PQ protocols for continuous extrusion and bitumen lines, ensuring product properties such as thickness and tensile strength. You will establish CPPs, run DOE studies, and analyze data with Minitab/JMP to define robust operating windows.

You will collaborate with R&D, Maintenance, CI and Production to transfer new formulations to full-scale production and draft SOPs while driving CAPA and change-management activities.

Qualifications

• 3–5+ years of process engineering or validation experience in a continuous manufacturing environment
• Experience in plastics extrusion, polymer film processing, calendering, or flexible web-handling systems
• Deep understanding of film/foil production, coating processes, and standard processing equipment (extruders, calendars, mixers)
• Proficiency with IQ/OQ/PQ methodologies and SPC software

Responsibilities

• Design, write, and execute IQ/OQ/PQ protocols for continuous extrusion and bitumen production lines
• Establish and validate CPPs to guarantee consistent product properties
• Evaluate manufacturing data using Minitab or JMP to assess process capability, determine operating windows, and conduct DOE
• Drive RCA and implement CAPA for out-of-spec deviations
• Manage Engineering Change Orders to ensure re-validation of modifications
• Collaborate with R&D, Maintenance, CI, and Production to transfer formulations from pilot to full-scale production
• Draft clear technical protocols, summaries, and SOPs

Skills

IQ/OQ/PQ methodologies

Structured problem-solving

SPC software

Lean Six Sigma (Black/Green Belt)

AI-based tools

Communication across teams

Design of Experiments (DOE)

Education

Bachelor's/Master's/PhD in a relevant engineering field

Tools

Minitab

JMP

Job description

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)