Job Title: MES Implementation Specialist (Contract)
Location: Waterford, Ireland (On-site 3-5 days/week)
Duration: 3-6 months
Level: Mid-level (2-4 years' experience)
Project Overview
A leading pharmaceutical client is seeking two MES Consultants to support the implementation of electronic Master Batch Records within their manufacturing execution system. The project focuses on filling and lyophilization processes.
Key Responsibilities
* Conduct fit-gap assessments and process mapping to support eMBR configuration.
* Model and configure Master Recipes in PAS-X 3.3 in line with project standards.
* Author and review functional documentation including Functional Specs, Master Data definitions, and UAT scripts.
* Support dry-runs and UAT execution, including anomaly tracking and resolution.
* Install Master Recipes in Pre-Production and Production environments.
* Deliver application expertise and hypercare support during go-live.
* Act as a functional SME for filling and lyophilization processes.
Required Skills and Qualifications
* 2-4 years of hands-on experience with Korber PAS-X MES, ideally in a GMP-regulated environment.
* Experience configuring and implementing Master Recipes.
* Strong documentation and validation experience.
* Understanding of sterile manufacturing and lyophilization processes is a plus.
* Excellent communication skills and ability to work effectively on-site with cross-functional teams.