Summary: Our client, a leading biopharmaceutical company in Co.
Kerry, is seeking an MES Engineer to support the development of Batch Records and Electronic Batch Records (EBRs) for a new manufacturing operation.
Working closely with Process team members, the successful candidate will translate existing process flow diagrams into clear, compliant manufacturing instructions and develop corresponding EBR templates within the sites MES platform.This position offers hybrid working, with three days on-site and two days off-site per week.
Responsibilities: Develop paper Batch Records based on existing process flow diagrams, process descriptions and equipment workflows.
Create Electronic Batch Record (EBR) templates that reflect process steps, material requirements, equipment usage and in-process controls.
Collaborate with Process Engineers to confirm process logic, sequence of operations, equipment capabilities and material flows.
Support MES configuration activities to ensure EBR templates align with site standards, manufacturing workflows and compliance requirements.
Ensure all Batch Records and EBRs meet GMP expectations for clarity, accuracy, data integrity and execution readiness.
Participate in document walkdowns and process reviews to ensure manufacturing instructions match real process conditions.
Work with Manufacturing, QA and Automation teams to incorporate feedback and ensure operational suitability of Batch Records and EBRs.
Support testing and verification of EBR templates during MES build, including troubleshooting and adjustments as needed.
Maintain version-controlled documentation, including specifications, change records and template revisions.
Contribute to improvements in documentation structure, process efficiency and digital workflow development.
Qualifications & Experience: Degree in Engineering, Science, Computer Science, IT/Automation or a related field.
Experience in GMP pharmaceutical or biopharmaceutical manufacturing.
Previous involvement in Batch Record creation or support of manufacturing documentation.
Experience with MES systems or Electronic Batch Records is highly desirable.
Strong understanding of process workflows, batch processing and manufacturing documentation.
Familiarity with GAMP 5, data integrity principles and computerised system expectations.