Process Engineer - Continuous Improvement

NEW GENERATION WELLNESS - 1.1

Colorado Springs, CO Job Details Full-time $110,000 - $130,000 a year 9 hours ago Benefits Paid holidays Health insurance Dental insurance 401(k) Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Defect resolution root cause analysis Preventive action implementation Statistical Process Control Production deviation management Corrective and preventive actions (CAPA) GMP Quality improvement programs in engineering Manufacturing company experience FDA regulations Failure analysis Full Job Description Process Engineer - Continuous Improvement New Generation Wellness (NGW) we are celebrating a century of commitment to health, vitality, and positive transformation. For 102 years, we've been at the forefront of wellness, pioneering innovation and shaping the future of holistic health. We invite you to be part of our legacy. Joining New Generation Wellness means becoming a part of a dynamic and successful team that values innovation, collaboration, and exceeding the needs of our customers.

Position Summary:

The Process Engineer - Continuous Improvement is responsible for improving the performance, consistency, and cost of NGW's existing nutraceutical manufacturing processes. This role owns yield, First Time Right, downtime, and overall equipment effectiveness (OEE) on commercial production lines, leads root cause analysis and corrective action for process-related deviations, and drives a prioritized continuous improvement roadmap. The role partners closely with Operations, Quality, and Product Development, and all process changes are made in compliance with cGMP and through NGW's change control process.

Essential Functions and Basic Duties:

Line Performance Own process performance metrics for existing lines, including yield, First Time Right, scrap and downtime. Analyze production data to identify the largest sources of loss and lead projects to reduce them. Process Control Maintain Critical Process Parameters, Critical Quality Attributes, and control strategies for commercial products. Apply process capability analysis and statistical process control to monitor and reduce process variability. Design and execute waste stream and value stream mapping studies, bolster first-pass quality metric (internally denoted as 'First Time Right' metric), and increased cost savings for the organization. Author and execute revalidation and qualification protocols (IQ/OQ/PQ) when processes or equipment change, in compliance with 21 CFR Part 111. Root Cause and Corrective Action Lead investigations and root cause analysis for process-related deviations and out-of-specification results. Author CAPAs in partnership with Quality Assurance and verify their effectiveness. Review quality trends to identify recurring process issues. Continuous Improvement Maintain a living continuous improvement roadmap for all manufacturing lines, prioritized by impact on quality, throughput, and cost. Lead value stream mapping, waste reduction, and Kaizen efforts using Lean and Six Sigma methods. Lead or support equipment improvement projects, including procurement, FAT/SAT, installation, and qualification. Floor Support and Development Provide technical support to Operations on process issues and train operators on process changes and best practices. Maintain process documentation, including SOPs and manufacturing batch records, through change control with Operations, Product Development, and Quality Assurance. Support the handoff of new products to manufacturing by reviewing processes for manufacturability and supporting initial production runs. Support new product transfer to manufacturing for initial product runs. Track and report manufacturing metrics, including first-pass yield, scrap, machine utilization, and deviation frequency, with Operations. Qualifications Education /

Certifications:

Bachelor's degree in chemical, mechanical, industrial, or materials engineering, or a related field.

Required Experience:

3+ years of process engineering experience in a regulated manufacturing environment, such as nutraceuticals, pharmaceuticals or 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.

Preferred Experience:

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.

Skills and Abilities:

Proficiency with statistical analysis and process capability tools. Physical Requirements The physical demands described here represent those an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

What We Offer:

Medical, Dental and Vision insurance effective upon hire 401(K) with company match PTO and Paid Holidays Employee supplement discounts and free quarterly supplements

Benefits:

401(k) Dental insurance Employee assistance program Health insurance Life insurance Paid time off Retirement plan Vision insurance