Senior Business Systems Validation Engineer

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

Company Description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

We are hiring a Senior Business Systems Validation Engineer to join AbbVie Cork. This role focuses on validation and technical support for manufacturing business systems, particularly MES support for SAP and POMSnet. You will also lead validation activities for the implementation of these systems within the manufacturing environment. In addition, you will support new technology introduction, process improvement, GMP compliance, and troubleshooting throughout the commercial product lifecycle.

What You'll Do

• 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.

Qualifications

• Bachelor's degree in Engineering, Science, or a related discipline preferred, or equivalent relevant experience.
• 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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.

Equal Opportunity Employer/Veterans/Disabled.US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation,