Cognizant is seeking a dedicated and driven MES Engineer to join our team in Dublin. As an MES Engineer, you will be responsible for implementing System/MES recipe changes and managing day-to-day issues that arise in the support of Electronic Batch Records, Weigh and Dispense, and Equipment Management modules on our Emerson Syncade MES solution.
Key Responsibilities:
* Maintain the incident queue in Service Now and manage and resolve issues as they arise in a timely manner
* Initiate and implement change control activities in accordance with quality standards and practices
* Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements
* Prioritise support activities in line with project schedules
Requirements:
* A minimum of 3 years of experience supporting IT applications, e.g. troubleshooting, managing incidents and change controls, design documentation, test case development, system and integration testing
* Create business process flow diagrams for pharmaceutical product recipes based on paper batch records or source documents
* Gather MES site-specific requirement analysis to develop User Requirements Specifications (URS) and Functional Requirements Specifications (FRS)
* Logically break down manufacturing processes to configure recipes in Werum PAS-X
* Develop/create Master Batch Record (MBR) design elements (building blocks) and workflows in Werum PAS-X for repetitive use in MBR creation to expedite the process
* Gather master data and configure it in Werum PAS-X Development/Quality/Production Environment
* Integrate Werum PAS-X with SAP and other automation systems using standard interface components of MBR design
* Lead recipe design sessions with business process Subject Matter Experts (SMEs)
* Design MBR/recipe equipment workflow/status diagrams based on business process flows
* Create solution design and configuration documents
* Prepare key user training documents and impart key user training
* Provide assistance in business Standard Operating Procedure (SOP) creation
Preferred Qualifications:
* An Intermediate level of Werum PAS-X experience
* Werum PAS-X product hands-on experience for full application configurations, including interfaces with SAP and automation systems
* In-depth knowledge of bio-pharmaceutical processes
* Creation of business process flow diagrams
* Master Batch Record creation in Werum PAS-X
* Knowledge of industry standards S88 and ISA S95
* Pharmaceutical validation concepts cGMP and GDP standards and GAMP Standards
* Good verbal and written communication skills
About Cognizant
Cognizant is a leading professional services company transforming clients' business, operating, and technology models for the digital era. Our unique, industry-based consultative approach helps clients envision, build, and run more innovative and efficient businesses.