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Consultant MES EBR - May 2021

remote, remote
For one of our clients we are looking for an MES Electronic Batch Record (EBR) Architect
 
 
Tasks:
The project is related to implementing EBR for Pharma manufacturing in following MES software - Siemens OpCenter pharma / Werum Pas-X / Aspen MES software and involves implementing end to end EBR projects for our pharma customer. So we need a consultant that has prior experience of:
  • Defining pharma batch manufacturing processes, standardizing the steps
  • Designing central core EBR solution with a library of core solution covering MBR, Weigh and dispense, packing, simple to complex recipes, integration with ERP order receipt, order material receipts and returns.
  • Good knowledge of GMP (Good Manufacturing practices of Pharma) and validated environment of Pharma Manufacturing
 
Candidate must have strong experience of:
  • Experience of at least three EBR Implementation projects
  • Experience of designing MES EBR Core solution template, Master Batch record solutions for various pharma manufacturing clients
  • Have strong knowledge of consulting in standardizing batch processes, harmonizing processes across plants for similar drug manufacture
  • Knowledge of Pharma Manufacturing , Pharma Regulations such as GMP
  • Strong experience of pharma Validation
  • Strong proven experience of designing Master batch records, implementing simple to  complex recipes, Electronic batch records
  • Mandatory Knowledge of implementing MES EBR solutions on one of following platforms - Siemens OpCenter Pharma  /   / Werum Pas-X / Aspen
  • Ability to lead design and development of EBR Core solution and libraries
  • Ability to lead global plant implementations or EBR
  • Strong stake holder management experience and complex project management experience in pharma manufacturing environment
  • Candidate must have strong client facing skills in some of the following industries  - Pharma manufacturing / Food and Beverages Manufacturing
 
Primary Skills (Must have):
  • Candidate must have strong client facing skills in some of the following industries  - Pharma manufacturing / Food and Beverages Manufacturing
  • Experience of designing MES EBR Core solution template, Master Batch record solutions for various pharma manufacturing clients
  • Have strong knowledge of consulting in standardizing batch processes, harmonizing processes across plants for similar drug manufacture
  • Very strong communication skills for interacting with site stakeholders for batch process harmonization
  • Knowledge of Pharma Manufacturing , Pharma Regulations such as GMP
  • Strong experience of pharma Validation
  • Strong proven experience of designing Master batch records, implementing simple to  complex recipes, Electronic batch records
  • Mandatory Knowledge of implementing MES EBR solutions on one of following platforms - Siemens OpCenter Pharma /   / Werum Pas-X / Aspen
  • Ability to lead design and development of EBR Core solution and libraries
  • Ability to lead global plant implementations or EBR
  • Strong stake holder management experience and complex project management experience in pharma manufacturing environment
 
Start: ASAP
Duration: 6 months+
Location: remote

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