Process Characterization Engineer: DOE & Qualification

Novozen Healthcare LLC; Ohio; Presencial; USD 52.000 - 58.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) retirement plan

Paid time off

Descripción de la vacante

Novozen Healthcare LLC is seeking a technical characterizations specialist to develop and execute equipment and process characterization protocols, including DOE studies, parameter mapping, and sampling. You will troubleshoot issues and perform root cause analysis to ensure equipment readiness for commissioning and qualification activities.

In this role, you will analyze study data, prepare technical reports, and collaborate with Engineering, Validation, Quality, and Manufacturing teams to

Formación

• Experience in equipment or process characterization within a manufacturing environment.
• Knowledge of protocol development, execution, and technical report writing.
• Experience with troubleshooting and root cause analysis.
• Understanding of DOE, parameter mapping, sampling studies, and statistical analysis.
• Assembly or packaging equipment experience is strongly preferred.
• Pharmaceutical or GMP manufacturing experience is preferred.
• Commissioning and equipment qualification experience is a plus.

Responsabilidades

• Develop, execute, and document equipment and process characterization protocols.
• Conduct characterization studies, DOE, engineering runs, parameter mapping, and sampling studies.
• Troubleshoot equipment and process issues and perform root cause analysis.
• Support commissioning, startup, and equipment qualification activities.
• Analyze study data and prepare technical reports with recommendations.
• Work with Engineering, Validation, Quality, and Manufacturing teams to resolve issues and ensure equipment readiness.

Conocimientos

Characterization

DOE knowledge

Root cause analysis

Technical report writing

Assembly or packaging equipment

Descripción del empleo

Novozen Healthcare LLC is seeking a technical characterizations specialist to develop and execute equipment and process characterization protocols, including DOE studies, parameter mapping, and sampling. You will troubleshoot issues and perform root cause analysis to ensure equipment readiness for commissioning and qualification activities.

In this role, you will analyze study data, prepare technical reports, and collaborate with Engineering, Validation, Quality, and Manufacturing teams to