Scale Up Process Engineer

The Process Scale Up Engineer is a hands on technical role responsible for the successful scale up and industrialization of new products and processes from laboratory, bench scale, or pilot scale development into full scale manufacturing. This role partners closely with R&D, Manufacturing, Quality, Safety, and Supply Chain to translate new technologies into robust, safe, and capable production processes while meeting quality, cost, and timeline objectives.

The Process Scale Up Engineer will lead technical transfers, define process parameters and control strategies, support first of kind manufacturing runs, and ensure new processes are designed for safety, quality, operability, and long term sustainability.

Responsibilities and Key Activities

Safety

• Champion safe design and scale up of new processes by applying Process Safety principles, hazard analyses (THA, JSA, etc.), and operational risk assessments during development and implementation.
• Support site Safety Programs through participation in audits, investigations, Gemba walks, and safety initiatives related to new product introductions.
• Ensure new equipment, materials, and processes are introduced in compliance with safety standards and regulatory requirements.
• Assist in the development of Standard Operating Procedures (SOPs) and training materials to ensure safe start up and operation of new processes.
• Actively drive and support safety related continuous improvement activities within the scale up scope.

Quality

• Partner with project teams to ensure new processes meet internal quality standards and meet customer requirements.
• Support development of critical to quality (CTQs), process capability, and control plans for new products and processes.
• Lead or support Root Cause Analysis (RCA) activities for issues discovered during trials, scale up runs, or early production using structured tools (5 Why, Fishbone, DOE, etc.).
• Lead or Support validation activities, change management, and documentation (PCAs, PTRs, new part numbers, bills of materials, specifications).
• Author documentation for knowledge transfer prior to full production release.

Process Scale Up & Productivity

• Lead the scale up of new products and processes from lab/pilot to commercial manufacturing, ensuring technical feasibility, robustness, and repeatability.
• Translate development scale data into manufacturing scale process parameters, material specifications, and operating windows.
• Design, plan, execute, and analyze trials and first article manufacturing runs, documenting learnings and driving design or process refinements. Use statistical tools such as design of experiments to identify process windows.
• Partner with Operations and Maintenance to troubleshoot technical issues during start up and ramp up phases.
• Collect, analyze, and interpret process data to support scale up decisions and optimize throughput, yield, and run time.
• Define and establish key process parameters and metrics and monitor performance during initial production.
• Identify CapEx needs for scale up activities, lead small CapEx projects, and support larger CapEx projects.

Continuous Improvement

• Apply Lean Manufacturing and Six Sigma principles to new process designs to minimize waste, variation, and cost.
• Support cross functional teams to improve OEE, capacity, and cost performance of newly introduced processes.
• Support Kaizen, 5S, and loss elimination activities related to new products or scaled up processes.
• Use project management tools to manage scale up projects with moderate to high technical complexity, including timelines, risks, and deliverables.
• Capture and standardize lessons learned to improve future scale up efforts.

Behavioral Competencies

• Accountability: Takes ownership of scale up outcomes and delivers results through disciplined execution.
• Collaboration: Works effectively across R&D, Operations, Quality, Supply Chain, and Engineering teams.
• Courage: Challenges assumptions and legacy practices to enable successful commercialization of new technologies.
• Passion: Demonstrates enthusiasm and urgency when bringing new products and processes to life.
• Respect: Treats all employees, contractors, and stakeholders with professionalism and respect.
• Science & Data Mindset: Uses data, experimentation, and sound engineering principles to guide decisions.

Technical Skills

• Process scale up and technology transfer
• Chemical and/or materials process knowledge
• Experimental design (DOE) and data analysis
• Modeling experience (JMP/Minitab, Aspen, etc.)
• Process control strategies and manufacturing specifications
• Equipment selection, commissioning, and start up support
• Root Cause Analysis and structured problem solving
• Lean Manufacturing and Continuous Improvement tools
• Project management fundamentals

Soft Skills

• Critical thinking and decision making
• Strong written and verbal communication
• Cross functional leadership and influence
• Organization, prioritization, and time management
• Continuous improvement and learning mindset

Education and Experience

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Materials Engineering, or related engineering field (preferred).
• Associate degree with equivalent relevant experience may be considered.
• Experience:
• 2+ years in process engineering, scale up, manufacturing engineering, or product/process development preferred.
• Experience supporting new product introductions, pilot scale trials, or manufacturing start ups is a strong plus.

Closing

The above statements are intended to describe the general nature and level of the work being performed by employees assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. MonoSol, LLC reserves the right to make changes to the job description whenever necessary.

Disclaimer

As part of MonoSol, LLC's employment process, finalist candidates will be required to complete a physical, drug/ alcohol test, and background check prior to employment commencing. MonoSol, LLC is an equal opportunity employer. All qualified applicants will be considered without regard to race, national origin, gender, age, disability, sexual orientation, veteran status, or marital status.