Senior Business Systems Validation Engineer
__jobinformationwidget.freetext.LocationText__
Cork, CO
- Operations
- On-Site
- Full-time
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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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.
- 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.
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:
- AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
- If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.
If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.
Protect yourself by verifying job offers and communications. Your safety is important to us.
Where We Work
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.