Job description
Company Description
👋🏼 We’re Nagarro.
We are a digital product engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale — across all devices and digital mediums, and our people exist everywhere in the world (17 500+ experts across 37 countries, to be exact). Our work culture is dynamic and non-hierarchical. We’re looking for great new colleagues. That’s where you come in!
By this point in your career, it is not just about the tech you know or how well you can code. It is about what more you want to do with that knowledge. Can you help your teammates proceed in the right direction? Can you tackle the challenges our clients face while always looking to take our solutions one step further to succeed at an even higher level? Yes? You may be ready to join us.
Job Description
- 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
Qualifications
- 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
Additional Information
Nice to have:
- Fluent in German (written and spoken).
- Rockwell Automation PharmaSuite
- Practical experience with DCS, especially Siemens PCS7 and Simatic Batch
