MES Engineer

Summary

Join Nagarro, a global digital product engineering company, and participate in designing and implementing recipes and electronic batch records within a Manufacturing Execution System (MES). You will ensure successful manufacturing production runs by assessing risks, implementing preventive measures, and troubleshooting process issues. This role requires completing training to maintain technical skills and cGMP compliance, sharing knowledge with others, and designing production processes and master data within the MES. You will also create and maintain recipe documentation and configure system functions based on business requirements. Conducting recipe tests and collaborating with business departments are also key responsibilities.

Requirements

• Bachelor's degree (chemical engineering/engineering/business informatics, or equivalent exposure to the IT industry or business analysis)
• Between 4-6 years' experience in working with the Manufacturing industry/shopfloor (functional or technical), preferably in the pharma domain
• MES experience with any of the leading MES products (preferred Rockwell Automation PharmaSuite)
• Understanding of various client quality and manufacturing impacts involved with MES implementation, GxP systems implementation or software development life cycle as well as supporting project and validation methodologies (CSV)
• Professional experience in the pharmaceutical/biotech industry and expertise in GxP and regulations such as 21 CFR Part 11
• Knowledge of pharmaceutical manufacturing of biotechnology products and process development
• Experience with MES Recipe Authoring, Equipment Management Electronic Batch Record (EBR) design, or validation experience
• Willingness to gain additional knowledge of the MOM platform and integration capabilities

Responsibilities

• Participate in the design and implementation of recipes, electronic batch records within a Manufacturing Execution System (MES)
• Ensure successful manufacturing production runs by assessing risk, implementing preventive measures, investigating, and troubleshooting process issues related to MES
• Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements
• Ability to share complex principles of knowledge to others (team members, stakeholders, externals, or inspections) along with technical writing abilities
• Design and modeling of production processes in the form of electronic recipes and workflows in the MES (ex Rockwell PharmaSuite)
• Design and modeling of master data (e.g., equipment, product parameters, etc.)
• Creation and maintenance of recipe documentation according to the recipe lifecycle, from specification to formal testing and release
• Configuration of recipe and system functions based on business requirements
• Design and creation of process requirements in close collaboration with the business departments
• Conducting recipe tests

Preferred Qualifications

• Fluent in German (written and spoken)
• Rockwell Automation PharmaSuite
• Practical experience with DCS, especially Siemens PCS7 and Simatic Batch