Process & Equipment Characterization Engineer

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