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.

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.

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.

For further information on this role please contact Tommy McKeown on 086 0100903 / jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO

Tommy McKeown

JOB-11356