About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Data Integrity Engineer

Want to join an award winning team?

Ready to make a Worldwide impact?

 

Welcome to Abbvie!

 

We are now recruiting a Data Integrity Engineer to join our diverse Biologics Manufacturing team in Westport, Mayo. As our Data Integrity Engineer you will take ownership for a combination, computer engineering, systems engineering and control engineering. The DI Engineer works closely with Operations, QA, Engineering and Maintenance to drive data integrity requirements for the Business Unit.

 

So, what do you need to do this role?

 

Key Responsibilities  

• You will manage and drive data integrity requirements for the Business Unit.
• Lead and provide feedback to project owners on the status data integrity projects in the Business Unit.
• Support the Business Unit during audits from a data integrity perspective.
• Lead the generation and routing of data integrity and system-based documents through the Quality Assurance process.
• Complete data Integrity reviews and subsequent remediation activities of business unit systems and processes.
• Generate data process maps to describe the data flows throughout the systems and to identify critical data control points/transactions.
• Identify data integrity gaps and propose solutions.
• We believe in collaboration so in this role, you will partner with remediation activities including any potential validation activities to address identified process and/or equipment data integrity gaps.
• Lead and/or assist the development of critical alarm matrix for systems which will lead into procedural controls.
• Develop training modules to continue the upskill and awareness of data integrity across the business unit.
• Develop matrix of the systems access levels across users, set ups, administrators and engineers.
• You will comply with the data integrity of new installs and upgrades to meet Annex 11 and 21CFR Part 11
• Updating of the current system risk assessments and risk mitigation plans. Completion of risk assessments for new installs.
• Support personnel in effective audit trial reviews.

Qualifications

Education

 

• You will have a relevant third level qualification in an engineering, science or technical discipline (Degree Level Preferable)

 

Technical Skills and Experience

 

• Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.
• At least 3 years’ experience in a highly automated manufacturing environment
• Experience: SAP, Coral, Quality software systems, working with Microsoft Office (Word, Excel, PowerPoint etc.).

• Experience of working on a team, including strong organisational and time management skills.
• Ability to learn new and different technologies.
• Solution focused, with in-depth technical knowledge of both procedural controls and system controls for managing data Integrity.
• Motivated and passionate about production systems.
• Excellent documentation, organisational and prioritisation skills.
• Ability to effectively communicate plans, proposals, and actions at management levels.

• Total commitment to quality and a high standard of work always.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.