Characterization Engineer - Pharma Equipment & DOE

Intellectt Inc; Ohio; On-site; USD 90,000 - 130,000; Full time

Job summary

Intellectt Inc. is seeking a Characterization Consultant to support equipment and process characterization activities in a pharmaceutical manufacturing environment, with emphasis on assembly and packaging equipment.

You will develop and execute protocols, troubleshoot, and generate technical reports while challenging equipment against URSs to ensure design intent and operation. Ideal candidates have DOE and process characterization experience, data analysis skills, and familiarity with

Qualifications

• Experience conducting equipment and process characterization studies, including DOE, process characterization, engineering runs, parameter mapping, sampling studies, and statistical analysis.
• Comfort evaluating equipment performance, analyzing data, documenting results, troubleshooting, and developing recommendations from study outcomes.
• Experience with commissioning, equipment qualification, and technical documentation is highly desirable.
• Direct experience with assembly or packaging equipment is a strong plus, especially for URS challenging, root cause analysis, and commissioning/startup support in regulated manufacturing.
• Prior pharmaceutical or GMP experience is preferred.

Responsibilities

• Support equipment and process characterization activities in pharmaceutical manufacturing, focusing on assembly and packaging equipment.
• Develop, execute, and generate protocols; troubleshoot; perform root cause investigations; and prepare technical reports.
• Challenge equipment against URSs to verify design intent and operation; collaborate with Engineering, Validation, Quality, and Manufacturing to resolve issues.

Skills

DOE (Design of Experiments)

Process characterization

Data analysis

Root cause analysis

Equipment qualification

Technical documentation

Job description

Intellectt Inc. is seeking a Characterization Consultant to support equipment and process characterization activities in a pharmaceutical manufacturing environment, with emphasis on assembly and packaging equipment.

You will develop and execute protocols, troubleshoot, and generate technical reports while challenging equipment against URSs to ensure design intent and operation. Ideal candidates have DOE and process characterization experience, data analysis skills, and familiarity with