MES Engineer
MES Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 :
- Bachelors 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
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
Company Industry
Department / Functional Area
Engineering
Key Skills
- ASP.NET
- Health Education
- Fashion Designing
- Fiber
- Investigation
