Process Engineer: Drive Yield & OEE in GMP Manufacturing

Paycom - ATS; Stratton Meadows (CO); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Health insurance

Vision insurance

Life insurance

Paid time off

Retirement plan

Employee assistance program

Job summary

New Generation Wellness is seeking a Process Engineer to own line performance on commercial production lines, reduce losses, and drive measurable improvements in yield, OEE, scrap, and downtime. You will apply SPC, CAPA, and Lean Six Sigma to cut variability and sustain gains, partnering with Operations, Quality, and Product Development.

Relocation assistance to Colorado Springs is available, and you will lead equipment validation, change controls, and new product transfers while training

Qualifications

• 3+ years of process engineering in a regulated manufacturing environment.
• Hands-on expertise with at least one dosage form (tablets, capsules, powders, softgels, gummies).
• Working knowledge of cGMP under 21 CFR Part 111, 211, or 117A.
• Track record of improving yield, OEE, downtime, or first-pass quality with measurable results.

Responsibilities

• Own line performance: Yield, First Time Right, scrap, downtime, and OEE on existing lines.
• Lead investigations into process deviations and OOS results; author CAPAs with QA.
• Build and maintain a prioritized continuous improvement roadmap across all lines.
• Lead value stream mapping, waste reduction, and Kaizen events using Lean and Six Sigma.
• Lead or support equipment projects from procurement through FAT/SAT, IQ/OQ/PQ under 21 CFR Part 111.
• Train operators on process changes and maintain SOPs and batch records through change control.

Skills

Yield improvement

OEE optimization

Statistical analysis

Root cause analysis

CAPA investigations

Kaizen

Lean Six Sigma

cGMP knowledge

ERP knowledge

Education

Bachelor's degree in chemical, mechanical, industrial, or materials engineering

Tools

Deacom ERP

Electronic quality systems

Job description

New Generation Wellness is seeking a Process Engineer to own line performance on commercial production lines, reduce losses, and drive measurable improvements in yield, OEE, scrap, and downtime. You will apply SPC, CAPA, and Lean Six Sigma to cut variability and sustain gains, partnering with Operations, Quality, and Product Development.

Relocation assistance to Colorado Springs is available, and you will lead equipment validation, change controls, and new product transfers while training