Process Characterization Engineer for GMP Medical Devices

Fusion Life Sciences Technologies LLC; Columbus (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Fusion Life Sciences Technologies LLC in Columbus, OH is seeking a Process & Equipment Characterization Engineer to support characterization of assembly and packaging equipment in regulated pharma/medical device manufacturing. You will design and execute characterization studies (DOE, engineering runs, sampling), analyze data with Minitab, and report on IQ/OQ/PQ protocols to GMP standards.

Collaboration across engineering, validation, quality, automation, and manufacturing ensures equipment

Qualifications

• 4 years of experience in manufacturing, process, or validation engineering in a regulated environment.
• Hands-on process characterization experience including DOE and process window definition.
• Strong statistical analysis skills (SPC, Cp/Cpk, MSA/Gage R&R); Minitab preferred.
• Experience with IQ/OQ/PQ qualification protocols and GMP/ISO 13485 familiarity.

Responsibilities

• 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

Skills

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

Job description

Fusion Life Sciences Technologies LLC in Columbus, OH is seeking a Process & Equipment Characterization Engineer to support characterization of assembly and packaging equipment in regulated pharma/medical device manufacturing. You will design and execute characterization studies (DOE, engineering runs, sampling), analyze data with Minitab, and report on IQ/OQ/PQ protocols to GMP standards.

Collaboration across engineering, validation, quality, automation, and manufacturing ensures equipment