Automation Engineer – Data Integrity
Commutable from Galway, Mayo, Sligo
We are now recruiting a Data Integrity Engineer to join our diverse Biologics Manufacturing team in Co. 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.
- 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.
- 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.
For further information on this role please contact Tommy McKeown on 086 0100903 / firstname.lastname@example.org
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