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