Company Description
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 (18500+ experts across 26 countries, to be exact). Our work culture is dynamic and non-hierarchical. We are looking for great new colleagues. That is where you come in!
Job Description
- 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
Qualifications
- Bachelor's degree (chemical engineering / engineering / business informatics or equivalent exposure to the IT industry or business analysis)
- 4-6 years' experience in working with the Manufacturing industry / shopfloor (functional or technical) preferably in pharma domain
- Nice to have: German language, Rockwell Automation PharmaSuite
Additional Information
- 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
Romania
