Compounder Process Engineer - 1st Shift Job Manitowoc area,Wisconsin USA,Engineering

Compounding Process Engineer

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).

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

Stand 30% of the time.
Sit 70% of the time.
Use hands to finger, handle or touch 100% of the time.
Reach above shoulders less than 10% of the time.
Climb or balance less than 10% of the time.
Talk or hear 50% of the time.
Taste or smell up to 10% of the time.
Lift up to 30 pounds up to 5% of the time.
Close Vision (clear vision at 20n inches or less).
Color Vision (ability to identify and distinguish colors).
Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).

Tools/Equipment Used

Various 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.