Process & Equipment Characterization Engineer

Position: Process & Equipment Characterization Engineer

Location: Columbus, OH

Duration: 1+ year with extension

Hours per week: 40 +

Shift: 2nd and 3rd

Job Description:

Our client is seeking a Characterization Consultant to support equipment and process characterization activities within a pharmaceutical manufacturing environment, with a focus on assembly and packaging equipment. Day-to-day responsibilities will include protocol development, execution, and generation; troubleshooting; design documentation; root cause analysis; and technical report generation. Consultants will challenge equipment functionality and performance against User Requirement Specifications (URSs) to verify that systems meet design intent and operational requirements. Additional responsibilities may include commissioning support, identifying equipment deficiencies, investigating unexpected results, performing root cause investigations, and collaborating with Engineering, Validation, Quality, and Manufacturing teams to resolve technical issues and ensure equipment readiness.

The ideal candidate will have experience conducting equipment and process characterization studies, including Design of Experiments (DOE), process characterization, engineering runs, parameter mapping, sampling studies, and statistical analysis. Candidates should be comfortable evaluating equipment performance, analyzing data, documenting results, troubleshooting issues, and developing recommendations based on study outcomes. Experience with commissioning, equipment qualification, and technical documentation is highly desirable. Direct experience with assembly or packaging equipment is a strong plus, particularly for candidates who have challenged equipment against URSs, performed root cause analysis on equipment or process failures, and supported commissioning or startup activities in a regulated manufacturing environment. Prior pharmaceutical or GMP experience is preferred.

Required Qualifications

• At least 4 years of experience in manufacturing, process, or validation engineering within a regulated environment.
• Hands-on experience with process characterization, DOE, parameter optimization, and process window definition.
• Strong statistical analysis skills, including SPC, process capability analysis (Cp/Cpk), and Measurement System Analysis (MSA/Gage R&R).
• Experience with equipment qualification, including IQ/OQ/PQ, and protocol authoring and execution.
• Experience with root cause analysis, PFMEA, and Control Plans.
• Familiarity with applicable FDA regulations, including 21 CFR Part 820 and Parts 210/211, ISO 13485, and GMP requirements.
• Strong analytical, troubleshooting, documentation, and cross-functional collaboration skills.
• Ability to work onsite in Ohio.

Skills: characterization, Protocols, Root cause, Troubleshooting