Process Engineer

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

Job title : Process & Equipment Characterization Engineer

Work location: Colombus, OH

Job Description

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.

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

Qualifications

• 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

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