Compounding Process Engineer – Scale-Up & Optimization

kdc/one, Northern Labs; Manitowoc (WI); On-site; USD 75,000 - 110,000; Full time

Job summary

kdc/one in Manitowoc, WI seeks a Compounding Process Engineer to design, optimize, and implement manufacturing processes for liquid consumer products. This role bridges R&D formulation and full-scale production, ensuring safe, efficient, and compliant operations.

Responsibilities include optimizing production capacity, developing process strategies, and documenting procedures in line with FDA cGMP and OSHA standards.

Qualifications

• BA/BS degree required or equivalent experience.
• Background with cGMP and FDA compliance preferred.
• Demonstration of strong detail orientation and ability to multitask.
• Proficient with Process Flow Diagrams (PFDs) and P&IDs.

Responsibilities

• Analyze existing compounding processes to identify inefficiencies and waste using Lean Six Sigma methods.
• Establish and document operating parameters for batch processing.
• Lead pilot runs and first-production batches, troubleshooting deviations.
• Support specification, sourcing, installation, and commissioning of new equipment (mixing tanks, CIP/SIP systems).
• Create and maintain process documentation in line with regulatory requirements.

Education

BA/BS degree in science or equivalent experience

FDA cGMP awareness

Tools

CAD software

Job description

kdc/one in Manitowoc, WI seeks a Compounding Process Engineer to design, optimize, and implement manufacturing processes for liquid consumer products. This role bridges R&D formulation and full-scale production, ensuring safe, efficient, and compliant operations.

Responsibilities include optimizing production capacity, developing process strategies, and documenting procedures in line with FDA cGMP and OSHA standards.