Senior MES Validation Engineer - SAP/EBR & GMP Innovator

AbbVie Inc.; Colorado Springs (CO); On-site; USD 110,000 - 150,000; Full time

Job summary

AbbVie Inc. in the United States is seeking a Senior Business Systems Validation Engineer to join our manufacturing IT team.

This role focuses on validation and technical support for MES-based systems such as SAP and POMSnet, and you will lead validation activities for implementations within the manufacturing environment. Responsibilities include maintaining data integrity, supporting lifecycle activities, audits, and ensuring cGMP compliance.

Qualifications

• Bachelor’s degree in engineering, science, or equivalent.
• 5–10 years in MES/automation validation in GMP/pharma.
• Experience with SAP and MES/EBR validation.
• Knowledge of GAMP 5 and EU Annex 15.
• Experience with data historians (OSI PI) is a plus.
• Strong project management and communication skills.
• Ability to work independently and in teams.

Responsibilities

• Validate MES systems (EBR, SAP) and support system upgrades.
• Lead validation activities for SAP and POMSnet implementations.
• Maintain data integrity and perform risk assessments.
• Support product lifecycle activities and change controls.
• Assist audits and ensure cGMP compliance.
• Contribute to digital transformation and AI-driven initiatives.

Skills

MES validation

ERP SAP

GAMP 5

EU Annex 15

Data security risk assessments

Project management

Communication skills

Independent / teamwork

Education

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

Tools

SAP

POMSnet

OSI PI

Job description

AbbVie Inc. in the United States is seeking a Senior Business Systems Validation Engineer to join our manufacturing IT team.

This role focuses on validation and technical support for MES-based systems such as SAP and POMSnet, and you will lead validation activities for implementations within the manufacturing environment. Responsibilities include maintaining data integrity, supporting lifecycle activities, audits, and ensuring cGMP compliance.