As the CSV/Data Integrity Engineer, you will be responsible for 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.
Your Key Responsibilities:
- Lead the generation and routing of data integrity and system-based documents through the Quality Assurance process.
- 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.
- 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.
- 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.
Your Skills and Experience:
- Level 8 Honours degree in Engineering.
- 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.
For more information, please contact Emma on 091 455 307.
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