Compounder Process Engineer - 1st Shift
kdc/one, Northern Labs · Manitowoc, WI · 3 wk ago
ManagementFull-time
Description / Scope / Mission
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.
Key Responsibilities/ Accountabilities
- 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.
Education / Certification / Qualifications / Experience
- BA/BS degree in a field of science required or equivalent experience.
- Background with cGMP and FDA compliance preferred.
- Demonstration of strong detail orientation, organizational skills and the ability to work independently and multi-task.
- Proficient with Process Flow Diagrams (PFDs), Piping and Instrumentation diagrams (P&IDs) and CAD software.
- Experience: Minimum of 2 years as process or manufacturing engineer. Direct experience with liquid consumer products is preferred.
Specific Knowledge
- Fluid mechanics, rheology, compounding equipment
Tools/Equipment Used
- Variety of hand tools, computer, telephone, copier and fax.
Work Environment/PPE Required
- Exposure to wet, humid conditions (non-weather); exposure to chemical manufacturing environment; exposure to outdoor weather conditions; vibration; and work/job related travel up to 1/3 of the time.
- Work near moving mechanical parts 1/3 to 2/3 of the time.
- Exposure to moderate noise.
- Wear PPE as required, not limited to safety glasses, steel toed shoes, etc.