Compounder Process Engineer - 1st Shift

KDC OneManitowoc, WI
Onsite

About The Position

The Compounding Process Engineer focuses on the design, optimization, and implementation of manufacturing processes for liquid domestic and consumer products. This role bridges the gap between R&D formulation and full-scale commercial manufacturing, ensuring that production processes are safe, efficient, robust, and capable of consistently meeting quality standards. Executes activities to support implementation of new projects and equipment specification and design in Compounding areas to increase capacity, set up / optimize production and reduce costs. Responsible for developing and implementing process strategies, managing resources, optimizing current processes and creating and maintaining documentation in line with the customer expectations and the regulatory requirements (FDA cGMP, OSHA, DNR).

Requirements

  • BA/BS degree in a field of science required or equivalent experience.
  • Minimum of 2 years as process or manufacturing engineer.
  • Proficient with Process Flow Diagrams (PFDs), Piping and Instrumentation diagrams (P&IDs) and CAD software
  • Fluid mechanics, rheology, compounding equipment

Nice To Haves

  • Background with cGMP and FDA compliance preferred.
  • Demonstration of strong detail orientation, organizational skills and the ability to work independently and multi-task.
  • Direct experience with liquid consumer products is preferred.

Responsibilities

  • Analyze existing compounding processes to identify inefficiencies, bottlenecks, and waste.
  • Implement Lean Manufacturing and Six Sigma methodologies to improve yield and cycle times.
  • Establish, validate, and document standard operating parameters (e.g., optimal viscosity, temperature ranges, shear rates) for batch processing.
  • Partner with Customers and R&D to transition new formulations from bench/pilot scale to mass production plants.
  • Determine the appropriate blending equipment, agitator types, and raw material addition sequences required to maintain product integrity at commercial scale.
  • Lead and document pilot runs and first-production batches, troubleshooting any deviations in product texture, stability, or separation.
  • Assist in the specification, sourcing, installation, and commissioning of new manufacturing equipment, such as mixing and storage tanks, automated dosing systems, high-shear mixers, and Clean-in-Place (CIP) units.
  • Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and modified equipment in partnership with Validation engineer and Quality Manager.
  • Partner with Controls/Automation Engineers to optimize PLC sequences, batching software recipes, and inline instrumentation (flow meters, load cells, pH probes).
  • Serve as the technical lead for investigating batch failures, out-of-specification (OOS) incidents, or systemic process deviations, implementing sustainable engineering solutions (CAPA).
  • Design and validate CIP (Clean-in-Place) and SIP (Sanitization-in-Place) cycles to minimize water and chemical consumption while ensuring zero cross-contamination.
  • Ensure all process designs comply with environmental, health, and safety regulations (OSHA; FDA; DNR, etc.), incorporating proper venting, spill containment, and safe chemical handling features.
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