Process Engineer - Continuous Improvement

NEW GENERATION WELLNESS•Colorado Springs, CO

2d•$110,000 - $130,000•Onsite

About The Position

New Generation Wellness (NGW) is seeking a Process Engineer – Continuous Improvement to enhance the performance, consistency, and cost-effectiveness of its nutraceutical manufacturing processes. This role is crucial for optimizing yield, First Time Right, downtime, and overall equipment effectiveness (OEE) on commercial production lines. The Process Engineer will lead root cause analysis for process deviations, implement corrective actions, and manage a prioritized continuous improvement roadmap. Collaboration with Operations, Quality, and Product Development is key, ensuring all process changes comply with cGMP and NGW's change control procedures.

Requirements

Bachelor's degree in chemical, mechanical, industrial, or materials engineering, or a related field.
3+ years of process engineering experience in a regulated manufacturing environment (e.g., nutraceuticals, pharmaceuticals, food).
Hands-on process expertise in at least one relevant dosage form: tablets, capsules, powders, softgels, or gummies.
Working knowledge of cGMP requirements under 21 CFR Part 111, 211, or 117.
Demonstrated track record of improving yield, OEE, downtime, or first-pass quality with measurable results.
Experience leading root cause investigations and CAPAs.
Proficiency with statistical analysis and process capability tools.

Nice To Haves

Direct experience with manufacturing under 21 CFR Part 111, 211, or 117.
Experience across multiple dosage forms.
Experience with controlled documentation creation and modification.
Lean Six Sigma Green Belt or Black Belt, or equivalent demonstrated experience.
Experience with process validation and equipment qualification.
Experience with ERP systems (Deacom preferred) and electronic quality systems.

Responsibilities

Own process performance metrics for existing lines, including yield, First Time Right, scrap, and downtime.
Analyze production data to identify and address major sources of loss through project leadership.
Maintain Critical Process Parameters, Critical Quality Attributes, and control strategies for commercial products.
Utilize process capability analysis and statistical process control to monitor and reduce process variability.
Design and execute waste stream and value stream mapping studies.
Improve first-pass quality metrics ('First Time Right') and drive cost savings.
Author and execute revalidation and qualification protocols (IQ/OQ/PQ) for process or equipment changes, adhering to 21 CFR Part 111.
Lead investigations and root cause analysis for process-related deviations and out-of-specification results.
Author CAPAs in collaboration with Quality Assurance and verify their effectiveness.
Review quality trends to identify recurring process issues.
Maintain a dynamic continuous improvement roadmap for all manufacturing lines, prioritized by impact on quality, throughput, and cost.
Lead value stream mapping, waste reduction, and Kaizen initiatives using Lean and Six Sigma methodologies.
Lead or support equipment improvement projects, including procurement, FAT/SAT, installation, and qualification.
Provide technical support to Operations for process-related issues.
Train operators on process changes and best practices.
Maintain process documentation, including SOPs and manufacturing batch records, through change control with relevant departments.
Support the transition of new products to manufacturing by assessing manufacturability and assisting with initial production runs.
Track and report manufacturing metrics, such as first-pass yield, scrap, machine utilization, and deviation frequency, in conjunction with Operations.