The Recipe Author shall develop new Electronic Batch Records (eBRs) and revise existing eBRs using a library of existing work instructions and operations including creation of complex process recipes.
- Translate business requirements into a robust eBR design which is compliant, efficient, and effective.
- Coordinate the user acceptance testing of MES recipes with peers and internal customers to ensure business requirements are achieved.
- Develop validation test cases and perform testing ( IQ,OQ, PQ).
- Develop and provide operational and technical training.
- Train site users/Business SMEs.
- The MES Recipe Author shall provide technical and functional support to User group on addressing day to day production issues
- Provide periodic on-call support to internal customers for emergency system issues.
- Troubleshoot routine and complex problems to support internal customers.
Test, validate and demonstrate Master Recipes. - Assist in designing, testing, and maintaining the electronic batch record (EBR) MES Recipes and related Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
- Maintain the recipe release process to meet manufacturing requirements and to maintain compliant, efficient, and reliable electronic batch records and supporting data.
- Develop and execute change controls and master data change requests for master data and MES Recipe configuration changes.
Bachelor's degree and 6 or more years of related work experience
- Flair for coding what is on the clients mind
- Basic or advanced understanding of different client needs, sectors and business processes
- 6 or more years of significant experience within MES in manufacturing industry and extensive experience within the following: performing MES business requirements analysis and specifications, system design, application software configuration, development, testing, installation, start-up, and maintenance and providing guidance for, system integration and application design, architecture development and support for complex and generic MES platforms including but not limited to Rockwell and Werum PAS-X.
- Experience providing detailed and complex root-cause analysis support and maintenance to systems hardware and software as required.
- Experience in preparing written reports and technical evaluations, functional specifications, technical documents, and other assignments as required.
- Requires ability to work independently or as part of a team, depending upon project scope.
- Has completed at least 1 or more full MES lifecycle projects with proven results delivered
- Pharma domain knowledge
- Knowledge in GxP systems
Degree emphasis in Pharmacy or Mechanical.
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