Senior MES & SAP Validation Engineer

ABBVIE; Cork; Presencial; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

AbbVie Cork is seeking a Senior Business Systems Validation Engineer to lead validation for MES/ERP systems including SAP and POMSnet, support new product introductions, and drive GMP compliance in manufacturing.

The role emphasizes validation lifecycle, data integrity, change control, audits, and continuous improvement, with collaboration across QA, IT, and manufacturing to enable technology-enabled products.

Formación

• Bachelor’s degree in Engineering, Science, or a related discipline preferred, or equivalent relevant experience.
• 5–10 years’ experience in MES/automation systems validation within a pharmaceutical or GMP-regulated environment.
• Experience with laboratory and manufacturing equipment validation, computer system validation, GAMP 5, and EU Annex 15.

Responsabilidades

• Validate MES/EBR and SAP systems, including upgrades, issue resolution, continuous improvement, and production support.
• Support SAP and MES activities for new product introductions, including materials, BOMs, recipes, and system validation.
• Maintain data integrity and data security risk assessments, including remediation of legacy systems.
• Assist lifecycle activities: SOPs, investigations, study plans, protocols, reports, and batch record updates.
• Support new product introductions and technologies, including equipment selection, validation, and training.

Conocimientos

MES validation

SAP validation

GxP know-how

Project management

Communication skills

Educación

Bachelor’s degree in Engineering, Science, or related

Herramientas

SAP

POMSnet

OSI PI

GAMP 5

Descripción del empleo

AbbVie Cork is seeking a Senior Business Systems Validation Engineer to lead validation for MES/ERP systems including SAP and POMSnet, support new product introductions, and drive GMP compliance in manufacturing.

The role emphasizes validation lifecycle, data integrity, change control, audits, and continuous improvement, with collaboration across QA, IT, and manufacturing to enable technology-enabled products.