Senior MES & SAP Validation Engineer

AbbVie Inc.; Cork; On-site; EUR 70,000 - 100,000; Full time

Job summary

AbbVie Cork is seeking a Senior Business Systems Validation Engineer to lead validation and technical support for manufacturing business systems, with a focus on MES support for SAP and POMSnet. You will drive validation activities for implementation, support technology introduction, and ensure GMP compliance and continuous improvement across the product lifecycle.

The role involves validating MES systems, ERP SAP integration, data integrity, and risk assessments, while contributing to AbbVie’s

Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline.
• 5–10 years’ experience in MES/automation systems validation, new product introduction, and/or manufacturing support within a pharmaceutical or GMP-regulated environment.
• Experience with laboratory and manufacturing equipment validation, computer system validation, GAMP 5, and EU Annex 15.
• Knowledge of process performance qualification, cleaning validation, hold time studies, and validation lifecycle activities.
• Experience supporting ERP SAP systems and MES/EBR implementation.
• Familiarity with data historians such as OSI PI and reporting tools is an advantage.
• Strong project management, problem-solving, and communication skills.
• Ability to work independently and as part of a team, with good people management skills and strong organizational capability.
• Comfortable working under pressure, prioritizing workload, and meeting tight deadlines.

Responsibilities

• Support validation and production activities for MES systems e.g. EBR and SAP, including system upgrades, issue resolution, continuous improvement, and ongoing production support.
• Support SAP and MES activities for new product introductions, including creation of new materials, BOMs, recipes, and system validation.
• Maintain data integrity and data security risk assessments, including support for remediation of legacy systems.
• Support product lifecycle activities, including SOP updates, investigations, study plans, protocols, reports, change plans, annual product reviews, and batch record updates.
• Support the introduction of new products and new technologies, including equipment selection, validation, training, and process support.
• Provide validation guidance for automation and business systems changes, including suitability assessments and VRB assessments where applicable.
• Write and execute validation protocol for , cleaning, equipment, utilities, facilities, automation and process.
• Support change control activities, validation documentation review and approval, and cross-functional project groups.
• Support audit readiness and participate in GMP, corporate, and supplier audits.
• Maintain compliance with cGMP, FDA, IMB, GxP, safety, and environmental requirements.
• Actively contribute to AbbVie’s operational excellence and digital transformation goals by embracing AI tools, data-driven decision-making, and continuous improvement practices.
• Comply with all applicable health, safety, and environmental policies, procedures, and regulations.

Skills

MES validation

GAMP 5

Project management

Documentation

Quality systems

Data integrity

Education

Bachelor’s degree in Engineering, Science, or related discipline

Tools

SAP

OSIPI

MES/EBR

Reporting tools

Job description

AbbVie Cork is seeking a Senior Business Systems Validation Engineer to lead validation and technical support for manufacturing business systems, with a focus on MES support for SAP and POMSnet. You will drive validation activities for implementation, support technology introduction, and ensure GMP compliance and continuous improvement across the product lifecycle.

The role involves validating MES systems, ERP SAP integration, data integrity, and risk assessments, while contributing to AbbVie’s