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Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are now recruiting a Data Integrity Systems Engineer to join our Business Technology Solutions Team in Clonshaugh, Dublin. Working with counterparts in Manufacturing, QA, and Engineering departments, this role is central to the digital transformation of the Clonshaugh OSD site with key focus on data integrity. A key aspect of the role will require a strong focus on adhering to Data Integrity and Data Security controls for all manufacturing systems at the site
The role will work closely with the Automation Process Control systems team on all aspects of data integrity for all software components installed or being implemented within the Manufacturing plant. Additional responsibilities will include adhering to change control/management, configuration control, compliance to system security policies and data integrity along with coordinating systems patched, backups, and user management strategy.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities would be:
- Play a key role in the digital transformation and strategy of the Clonshaugh OSD site ensuring all transformation follows best practise data integrity principles
- Provide leadership from a data integrity perspective on control systems and IT systems used on manufacturing shopfloor•Following Data Integrity and Data Security policies and procedures for Control Systems and IT Systems on the manufacturing shopfloor, ensure systems are adherent to policies.
- Execute strategy to enable compliant systems backup and restores, patching, data archiving, and user accounts management. Where automated controls are not possible, ensure procedural controls are in place to strengthen Data Integrity and Data Security
- Provide data integrity support on all Process Control Systems and IT Manufacturing Systems in Clonshaugh Manufacturing Plant
- Support implementation, qualification, and maintenance of manufacturing IT systems (MES, Data historian, HMIs, PLCs, IPC, etc) and associate IT infrastructure that delivers operational efficiency and agility.
- Generate & Maintain documentation (SOP’s & Technical Documentation) for full GMP validation and operation, including documentation of changes made.
- Maintain Data Integrity and Data Security Program, including remediation of legacy systems to ensure robust procedure and systems are in place covering data integrity, security and recovery
- Contribute to the Automation & IT Business Strategy
- Define business continuity methods for IT element of manufacturing processes
So, what do you need to do this role?
Education & Experience
- You will have a relevant degree in information technology, Computer Science, Engineering, Mechatronics or similar with demonstrated working knowledge of POMSnet and / or other Manufacturing Execution systems to support OSD processes.
- 3 years technical experience in manufacturing systems, process automation, with relevant experience of batch processing SCADA Systems and DCS platforms in a GMP environment in the pharmaceutical industry desired
- Data integrity experience with automation systems by Siemens, Allen-Bradley, and Honeywell desired
- 3 years experience of the 21 CFR Part 11 requirements for manufacturing systems in the pharmaceutical industry.
- Computer Systems Validation experience
- Ability to work well under pressure, multi-task and meet deadlines
- Experience with OSI PI/data historian an advantage
- Broad knowledge of MS operating system, including server roles: AD, DNS, Virtualization, Remote Desktop, etc.
- Programming skills are a plus
So, are you ready to join our team? Apply today!
It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
Job Type: Experienced