Réalta Technologies

MES Validation Engineer (462)

Réalta Technologies  •  Cork, IE (Hybrid)  •  2 hours ago
Apply
Save Job
Mark Applied Mark Interviewed Mark Offered
Hide Job Report Job
AI can make mistakes so check important info. Chat history is never stored.

Job Description

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.
Réalta Technologies

About Réalta Technologies

Réalta Technologies is a Global Automation, Digital Systems and Data Analytics Company Headquartered in Cork, Ireland. From our offices in Ireland, the US and India, we provide world-class services and solutions to our clients all over the world.

We specialize in automation, process optimization, data-intelligence and data-driven technology solutions for businesses. We work with clients across many sectors, such as Pharma, Bio-Pharma, Med Device, FMCG, manufacturing and professional sports sectors.

Our team has broad knowledge and expertise across a wide range of technologies, platforms, and systems. This includes Engineering, Industrial Automation, IT Systems, Data Historians, Data Analytics and Consultancy.

We are an AVEVA endorsed system integrator who specialise in the delivery of advanced PI System solutions, as well as new PI system implementations, PI system expansions and 24/7 system support.

We are proud to be the Official Data Solutions Partner of Munster Rugby.

Industry
IT & Software
Company Size
51-200 employees
Headquarters
Ballincollig, IE
Year Founded
2017
Website
realtatechnologies.com
Social Media