Réalta Technologies is seeking an MES Validation Engineer to join a Digital Batch Record (DBR) implementation project at a leading pharmaceutical manufacturing facility in Cork.
Working alongside the Lead MES Validation Engineer, you will play a key role in supporting the validation lifecycle as the project progresses through the design approval and testing phases. This is an exciting opportunity to contribute to the successful deployment of Emerson Syncade MES within a GMP-regulated environment, ensuring the solution is delivered to the highest quality and compliance standards.
Job Responsibilities
- Support the validation of Emerson Syncade MES as part of a Digital Batch Record (DBR) implementation project.
- Review and approve design documentation, including Functional and Design Specifications, ensuring compliance with GMP and project requirements.
- Author, review and execute validation documentation including Validation Plans, IQ, OQ and test protocols.
- Perform system testing, document test results, investigate defects and support issue resolution throughout the validation lifecycle.
- Maintain traceability between user requirements, functional specifications and validation deliverables.
- Collaborate closely with MES, Automation, Quality, Manufacturing and Project teams to ensure successful project execution.
- Ensure all validation activities are performed in accordance with GAMP5, CSV principles, site procedures and regulatory requirements.
Job Requirements
- Degree in Engineering, Computer Science, Pharmaceutical Science or a related technical discipline.
- 3+ years' experience in MES Validation within a pharmaceutical or biotechnology GMP environment.
- Hands-on experience with Emerson Syncade MES, ideally supporting Digital Batch Record (DBR) implementations.
- Strong understanding of Computer System Validation (CSV), GAMP5, 21 CFR Part 11 and Annex 11 requirements.
- Experience authoring and executing validation documentation including Validation Plans, IQ/OQ protocols, test scripts and traceability matrices.
- Previous experience supporting design reviews, system testing and validation activities on pharmaceutical manufacturing projects.
- Strong communication, documentation and stakeholder management skills, with the ability to work effectively in a hybrid, cross-functional project environment.
