Toronto, Ontario

MBR Designer/MES Specialist

MBR Designer/MES Specialist
Long term project
1 year initial contract plus likely extensions
Toronto, ON
 
Our client is building a new vaccine manufacturing facility (B100) in Toronto. As part of a team of Master Batch Record designers, the MBR designer is responsible for modeling the manufacturing processes in a Manufacturing Execution System PAS|X.
 
This position will report to the MES Project lead and will be a key contributor to the Integrated Manufacturing Solutions team. The MBR designer will work closely with key stakeholders in a variety of departments within the B100 project to ensure that all operational requirements are met and the execution processes are fully integrated with ERP, PCS and data historian. The MBR designer will also participate the testing and validation of the MBR records.
 
 
Key accountabilities:
 
Key responsibilities of the MES Specialist shall include:
 
Creating and revising master batch records in the Werum PAS|X
Manufacturing Execution System. This position will be responsible for batch record
lifecycle management from creation of new records, revision, verification testing, and
change management
 
Configure, test, and maintain master batch records in PAS|X.
 
Create and manage equipment specification records for electronic equipment use
records.
 
Configure batch records to integrate with process control systems.
Facilitate design review workshops with process subject matter experts.
 
Troubleshoot batch records during floor operations.
 
Conduct training and share knowledge with team members.
 
Resolve issues, including presence in the production suite
 
Qualifications, Education and Experience
  • Demonstrated Execution Systems knowledge (MES, PCS, Data Historian) is preferred (3-5+ years)
  • Experience in pharmaceutical or related industry
  • Technical knowledge: GAMP, ISA 95, ISA 88, 21CFR part 11 is preferred
  • Demonstrated ability to work independently within project matrix structure
  • Demonstrated understanding of Good Manufacturing Practices, Health and Safety and Quality standards
 
 
 
 

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Heather MacKenzie

Directrice, Acquisition de talents

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