Senior Quality Engineer, CSV & Data Integrity Lead

Biopharma Asia; Athens (GA); Presencial; USD 79.000 - 128.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Vacation 120h

Sick time 40h

Floating holidays 13

Descripción de la vacante

Johnson & Johnson in Athens, GA is seeking a Senior Quality Engineer to drive quality leadership for computerized systems in a regulated environment. You will develop and execute Computerized System Validation (CSV) strategies, applying risk-based qualification and ensuring data integrity throughout the lifecycle.

The role partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to ensure systems are fit for use, appropriately controlled, and

Formación

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences or related technical discipline.
• 5+ years in Quality, Validation, Engineering, Automation, IT Quality or related function within regulated environments.
• Experience with computerized system validation and equipment/ system qualification.
• Ability to translate risk into validation/ qualification activities and review lifecycle documentation.

Responsabilidades

• Support qualification and validation activities for equipment and systems, including computerized systems.
• Apply risk-based approaches to determine scope and rigor of qualification/ validation.
• Review and approve validation plans, user requirements, specifications, risk assessments, test protocols, and traceability docs.

Conocimientos

Analytical Reasoning

Data Integrity

Problem Solving

Communication

Quality Management

Educación

Engineering/CS/IS/Life Sciences

Herramientas

LIMS

MES

ERP

EDMS

LMS

Descripción del empleo

Johnson & Johnson in Athens, GA is seeking a Senior Quality Engineer to drive quality leadership for computerized systems in a regulated environment. You will develop and execute Computerized System Validation (CSV) strategies, applying risk-based qualification and ensuring data integrity throughout the lifecycle.

The role partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to ensure systems are fit for use, appropriately controlled, and