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
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
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
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