Process Engineer – Regulated Pharma, Lean Six Sigma

Stark Pharma Solutions Inc; Salt Lake City (UT); On-site; USD 75,000 - 105,000; Full time

Job summary

Stark Pharma Solutions Inc in Salt Lake City, UT, is seeking a Process Engineer to support regulated manufacturing operations. The role emphasizes process improvement, root cause analysis, statistical analysis, Lean Six Sigma, and validation activities to enhance process performance and reduce variation.

You will collaborate with Manufacturing, Quality, and Engineering to implement data-driven solutions, perform characterization, and drive continuous improvement initiatives on-site.

Qualifications

• Experience in process improvement and continuous improvement initiatives.
• Experience in a regulated manufacturing environment.
• Strong root cause analysis and problem-solving skills.
• Experience with Minitab or comparable statistical software.
• Experience with DOE, SPC, and process capability analysis.
• Experience with validation activities (IQ/OQ/PQ) in manufacturing.
• Ability to work onsite five days per week.

Responsibilities

• Support and sustain manufacturing processes.
• Improve yield, output, quality, and process efficiency.
• Investigate manufacturing issues and identify root causes.
• Apply Lean Six Sigma, DMAIC, and continuous improvement methods.
• Perform process characterization and analyze manufacturing data.
• Use Minitab or similar statistical tools for process analysis.
• Support yield improvement, scrap reduction, and process efficiency projects.
• Support process, equipment, and component changes.
• Support IQ, OQ, and PQ validation activities.
• Troubleshoot manufacturing process issues with production teams.
• Collaborate with Manufacturing, Quality, and Engineering teams.
• Provide data-driven technical recommendations.

Skills

Lean Six Sigma

Root cause analysis

Statistical analysis

Process characterization

Minitab

Quality systems

Cross-functional collaboration

Onsite work

Education

Bachelor's degree in Engineering

Tools

Minitab

DOE

SPC

Process validation

Job description

Stark Pharma Solutions Inc in Salt Lake City, UT, is seeking a Process Engineer to support regulated manufacturing operations. The role emphasizes process improvement, root cause analysis, statistical analysis, Lean Six Sigma, and validation activities to enhance process performance and reduce variation.

You will collaborate with Manufacturing, Quality, and Engineering to implement data-driven solutions, perform characterization, and drive continuous improvement initiatives on-site.