Senior Process Engineer – Lean, Six Sigma, SPC & GMP

Entegee; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability insurance

401K plan

Commuter benefits

Paid leave

Job summary

Entegee in Madison, WI seeks an experienced Process Engineer to drive manufacturing excellence on-site. The role requires a minimum of five years in process engineering and hands-on experience with SPC and CI initiatives.

You will lead capital projects to reduce costs and improve process variability, implement Lean/Six Sigma/Kanban/Kaizen, write work instructions and procedures, and ensure compliance with FDA, GMP and ISO audits.

Qualifications

• Minimum of 5 years of process engineering experience in a manufacturing environment.
• Proven experience implementing SPC and continuous improvement initiatives.
• Knowledge of Lean Manufacturing, Six Sigma, Kanban, and Kaizen.
• Experience writing manufacturing work instructions and engineering procedures.
• Familiarity with FDA and GMP regulations and ISO audit compliance.
• Preferred: Experience in the pharmaceutical or medical device industry.
• Demonstrated history of steady employment.

Responsibilities

• Manage process controls to ensure consistent product quality and manufacturing efficiency.
• Lead capital projects focused on reducing manufacturing costs and improving process variability.
• Implement process improvements using Lean Manufacturing, Six Sigma, Kanban, and Kaizen methodologies.
• Develop and maintain work instructions, manufacturing procedures, and engineering documentation.
• Apply Statistical Process Control (SPC) to monitor and improve manufacturing processes.
• Ensure compliance with FDA, GMP, and ISO audit requirements.

Skills

Process engineering

SPC

Continuous improvement

Lean Manufacturing

Six Sigma

Kanban

Kaizen

Work instructions

Engineering procedures

FDA regulatory knowledge

GMP

ISO audit compliance

Pharma/Medical device exposure

Job description

Entegee in Madison, WI seeks an experienced Process Engineer to drive manufacturing excellence on-site. The role requires a minimum of five years in process engineering and hands-on experience with SPC and CI initiatives.

You will lead capital projects to reduce costs and improve process variability, implement Lean/Six Sigma/Kanban/Kaizen, write work instructions and procedures, and ensure compliance with FDA, GMP and ISO audits.