Process Re-engineering / Compliance

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
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.
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 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.
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.
Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.
Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.