Process Engineer – Equipment Characterization & Validation.
Hello, My name is Jahera, and I’m reaching out from Intellectt Inc. regarding a Process & Equipment Characterization Engineer contract opportunity in Ohio (Onsite) with one of our clients.
Position Details
Job Title: Process & Equipment Characterization Engineer
Location: Columbus OH (Onsite)
Job Description:
We are seeking a Process & Equipment Characterization Engineer to support assembly and packaging equipment characterization in a regulated pharmaceutical or medical device manufacturing environment. The role focuses on optimizing process parameters, establishing process windows, analyzing study data, and verifying equipment performance before and during qualification.
Key Responsibilities:
Design and execute process characterization studies, including DOE, engineering runs, parameter mapping, and sampling studies.
Analyze data using Minitab and statistical methods to assess process capability (Cp/Cpk) and identify process variation.
Author, execute, and document characterization and equipment qualification protocols, including IQ/OQ/PQ.Evaluate equipment against User Requirement Specifications (URS) to verify design intent and operational requirements.
Troubleshoot equipment and process issues and perform root cause investigations using 8D, 5-Why, and similar methodologies.
Identify equipment deficiencies and recommend data-driven improvements.
Support commissioning, installation, and startup of automated and PLC-controlled assembly and packaging equipment.
Develop and update PFMEAs, Control Plans, and technical reports.
Work with Engineering, Validation, Quality, Automation, and Manufacturing teams to resolve technical issues and ensure equipment readiness.
Required Qualifications:
At least 4 years of experience in manufacturing, process engineering, or validation engineering in a regulated environment.
Hands-on experience with process characterization, DOE, process parameter optimization, and process window definition.
Knowledge of SPC, Cp/Cpk, MSA, and Gage R&R; Minitab experience preferred.
Experience authoring and executing IQ/OQ/PQ protocols.
Experience with root cause analysis, PFMEA, and Control Plans.
Familiarity with FDA 21 CFR Part 820/210/211, ISO 13485, and GMP requirements.
Experience with assembly or packaging equipment is strongly preferred.
Commissioning and startup experience in a regulated manufacturing environment is highly desirable.
If you are interested in this opportunity, please share your updated resume with me at Jahera@intellectt.com or contact me at +1 (732) 276-1791.