MES Consultant (Engineer)

1 Week ago • 4-6 Years

About the job

SummaryBy Outscal

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

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