Senior Process Engineer - Lean Six Sigma & GMP Compliance

United Pharma; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking a senior process engineer in a manufacturing environment to drive product quality and efficiency. The role requires 5+ years of experience, strong knowledge of SPC and continuous improvement, and familiarity with FDA, GMP, and ISO audit requirements.

Preferred in pharma or medical devices, with a proven history of steady employment. Responsibilities include leading capital projects to reduce costs and variability, developing work instructions and procedures, applying

Qualifications

• Minimum 5 years of process engineering experience in manufacturing.
• 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.

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

Lean Manufacturing

Six Sigma

Kanban

Kaizen

Work instructions

GMP/FDA compliance

ISO audits

Pharma/Medical device (preferred)

Steady employment history

Job description

United Pharma is seeking a senior process engineer in a manufacturing environment to drive product quality and efficiency. The role requires 5+ years of experience, strong knowledge of SPC and continuous improvement, and familiarity with FDA, GMP, and ISO audit requirements.

Preferred in pharma or medical devices, with a proven history of steady employment. Responsibilities include leading capital projects to reduce costs and variability, developing work instructions and procedures, applying