Compounding Process Engineer: Scale-Up & Optimization

Kdc One; Manitowoc (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Kdc One Manitowoc, WI is seeking a Compounding Process Engineer to design, optimize, and implement liquid consumer product manufacturing processes. This role bridges R&D formulation and full-scale production, ensuring safety, quality, and efficiency while reducing costs.

You will support new projects from bench to mass production, set up and optimize production, and help meet regulatory requirements (FDA cGMP, OSHA, DNR) through robust process strategies and documentation.

Qualifications

• BA/BS degree in a science field or equivalent experience.
• Background with cGMP and FDA compliance preferred.
• Demonstration of strong detail orientation, organizational skills, and ability to work independently and multi-task.
• Proficient with PFDs, P&IDs and CAD software.

Responsibilities

• Analyze existing compounding processes to identify inefficiencies and waste; apply Lean and Six Sigma to improve yield and cycle times.
• Establish, validate, and document operating parameters for batch processing.
• Collaborate with Customers and R&D to scale new formulations from bench to mass production.
• Select blending equipment, agitator types, and material addition sequences to maintain product integrity at scale.
• Lead pilot runs and first production batches; troubleshoot deviations in texture, stability, or separation.
• Assist in sourcing, installation, and commissioning of new equipment including CIP units.
• Prepare IQ/OQ/PQ protocols in collaboration with Validation and Quality teams.
• Work with Controls/Automation to optimize PLC sequences and batch software recipes.
• Investigate batch failures and CAPA; implement sustainable engineering solutions.
• Design and validate CIP and SIP cycles to minimize water/chemical use and prevent cross-contamination.
• Ensure compliance with OSHA, FDA, DNR and related environmental, health and safety standards.

Skills

Lean Manufacturing

Six Sigma

Detail orientation

Multi-tasking

Education

BA/BS in science

Tools

PFDs

P&IDs

CAD software

Job description

Kdc One Manitowoc, WI is seeking a Compounding Process Engineer to design, optimize, and implement liquid consumer product manufacturing processes. This role bridges R&D formulation and full-scale production, ensuring safety, quality, and efficiency while reducing costs.

You will support new projects from bench to mass production, set up and optimize production, and help meet regulatory requirements (FDA cGMP, OSHA, DNR) through robust process strategies and documentation.