Process Engineer

Job title : Process & Equipment Characterization Engineer

Work location: Colombus, OH

Our client is seeking a Process & Equipment Characterization Engineer to support characterization of assembly and packaging equipment in a regulated pharmaceutical and medical device manufacturing environment. This role focuses on defining and optimizing process parameters, establishing process windows, and verifying that equipment meets design intent before and during qualification.

• Design and execute process and equipment characterization studies, including DOE, engineering runs, parameter mapping, and sampling studies, to establish process windows and optimal operating parameters
• Analyze study data using statistical tools such as Minitab to demonstrate process capability (Cp/Cpk) and identify sources of process variation
• Author, execute, and report on characterization and qualification protocols (IQ/OQ/PQ), documenting results and deviations to GMP standards
• Challenge equipment functionality and performance against User Requirement Specifications (URSs) to confirm systems meet design intent and operational requirements
• Troubleshoot equipment and process issues, investigate unexpected results, and lead root cause investigations using 8D, 5-Why, or similar methods
• Identify equipment deficiencies and develop data-driven recommendations based on study outcomes
• Support commissioning, installation, and startup of automated and PLC-controlled assembly and packaging equipment
• Develop and update PFMEAs, Control Plans, and technical reports based on characterization results
• Collaborate with Engineering, Validation, Quality, Automation, and Manufacturing teams to resolve technical issues and ensure equipment readiness

• 4 years of experience in manufacturing, process, or validation engineering in a regulated environment
• Hands-on experience with process characterization, including DOE, process parameter optimization, and process window definition
• Strong statistical analysis skills, including SPC, capability analysis (Cp/Cpk), and MSA/Gage R&R. Minitab experience preferred
• Experience with equipment qualification (IQ/OQ/PQ) and protocol authoring and execution
• Experience with root cause analysis, PFMEA, and Control Plans
• Familiarity with FDA 21 CFR Part 820/210/211, ISO 13485, and GMP requirements
• Direct experience with assembly or packaging equipment strongly preferred. Medical device or combination product experience is a plus
• Commissioning and startup experience in a regulated manufacturing environment highly desirable

Process Characterization, Equipment Characterization, DOE, Process Parameter Optimization, Cp/Cpk, SPC, MSA/Gage R&R, Minitab, IQ/OQ/PQ, URS, Protocol Authoring/Execution, Root Cause Analysis, 8D, 5-Why, PFMEA, Control Plans, Commissioning, Troubleshooting, Assembly Equipment, Packaging Equipment, Medical Device, GMP, ISO 13485