Data Integrity Engineer
Data Integrity Engineer
My client is a Galway based multination manufacturing site who are now recruiting a Data Integrity Engineer to join our diverse Biologics site Mayo. In your role as the 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.
Responsibilities if the role:
- 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.
- 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.
- Degree qualification in an Engineering, Science or other Technical discipline.
- 3+ years’ experience in a highly automated manufacturing environment
- Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.
- Experience with SAP, Coral, or Quality software systems would be beneficial.
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