Process Engineer

Intellectt Inc; Ohio; In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

DOE (Design of Experiments)

Process characterization

Data analysis

Root cause analysis

Equipment qualification

Technical documentation

Descrizione del lavoro

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.

Required Qualifications

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.