Sterile QA Engineer: Validation, CAPA & Process Improvement

SCHOTT AG; Lebanon (Lebanon County); Presencial; USD 85.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare benefits

Disability benefits

Paid time off

Supplemental benefits

Descripción de la vacante

SCHOTT AG is seeking a Quality Engineer for sterile products to validate and re-validate sterilization processes and lead process improvements. You will monitor quality KPIs and support clinical or customer-led rollouts while ensuring ISO 9001/13485 and cGMP compliance.

The role requires a strong background in chemistry or microbiology, plus substantial experience with investigations, validations, and data analysis. SAP and Minitab proficiency are preferred, with MS Office skills expected.

Formación

• Bachelor's degree in Chemistry, Microbiology, or related field.
• At least 5 years of experience as a Quality Engineer with sterile products.
• At least 3 years of experience in investigations, validations, instrument qualifications, and EM programs.
• Solid knowledge of ISO 9001, ISO 13485 and ISO 15378, and cGMP.
• Experience in glass forming or pharmaceutical industry is preferred.

Responsabilidades

• Validate and re-validate sterilization processes.
• Lead regional or customer-led improvement activities and support rollouts.
• Monitor quality KPIs for sterile products and implement improvements.

Conocimientos

Sterile QA

Root cause analysis

Process validation

cGMP knowledge

Analytical thinking

Educación

BSc in Chemistry or Microbiology

Herramientas

SAP

Minitab

MS Office

Descripción del empleo

SCHOTT AG is seeking a Quality Engineer for sterile products to validate and re-validate sterilization processes and lead process improvements. You will monitor quality KPIs and support clinical or customer-led rollouts while ensuring ISO 9001/13485 and cGMP compliance.

The role requires a strong background in chemistry or microbiology, plus substantial experience with investigations, validations, and data analysis. SAP and Minitab proficiency are preferred, with MS Office skills expected.