Process Engineer

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Process Engineer

Location

Salt Lake City, UT

Duration

Long Term

Job Overview

We are seeking a Process Engineer to support regulated manufacturing operations. The ideal candidate will have experience in process improvement, root cause analysis, statistical analysis, Lean Six Sigma, process characterization, and validation activities. This role will work closely with Manufacturing, Quality, and Engineering teams to improve process performance, reduce variation, and support continuous improvement.

Key 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.


• Support change control and quality system documentation.


• Troubleshoot manufacturing process issues with production teams.


• Collaborate with Manufacturing, Quality, and Engineering teams.


• Provide data-driven technical recommendations.

Required Qualifications

• Bachelor s degree in Engineering or a related engineering discipline.


• 3 10 years of Process or Manufacturing Engineering experience.


• Experience in a regulated manufacturing environment.


• Experience with Lean Six Sigma and continuous improvement methodologies.


• Strong root cause analysis and problem-solving skills.


• Experience with process characterization and statistical analysis.


• Experience with Minitab or comparable statistical software.


• Experience with process validation, equipment qualification, or related activities.


• Experience with change control and regulated quality systems.


• Experience with DOE, SPC, and process capability analysis is a plus.


• Experience with metal manufacturing processes is a plus.


• Experience with heat treatment, electropolishing, laser cutting, or precision manufacturing is a plus.


• Experience with plastics processing, extrusion, or injection molding is a plus.


• Experience in medical device manufacturing is a plus.


• Lean Six Sigma certification or formal training is a plus.


• Strong communication and cross-functional collaboration skills.


• Ability to work onsite five days per week.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.