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MES MBR Designer (PAS-X) - Pharmaceutical Industry

Amaris Consulting - 4 emplois
Toronto, ON
Publié il y a 3 jours
Détails de l'emploi :
Temps plein
Expérimenté

Job Title: MES MBR Designer (PAS-X) - Pharmaceutical Industry

Location: Ontario or Greater Toronto Area, Canada (or willing to relocate quickly)

Experience Required: Minimum 3 years in MES MBR Design

Contract Type: Full-time / Contract

Job Description

We are currently seeking a MES MBR Designer with hands-on experience in PAS-X to join our client in the pharmaceutical industry. This is a great opportunity for someone passionate about digital manufacturing and electronic batch records to contribute to a growing, fast-paced environment in Ontario.

Key Responsibilities

  • Design, develop, and test Master Batch Records (MBR), Electronic Batch Records (EBR), and global MBRs (gMBR) in PAS-X MES
  • Collaborate with process engineers, QA, and production teams to capture business requirements and translate them into compliant MBRs
  • Ensure all MBRs align with GMP, 21 CFR Part 11, and company standards
  • Participate in validation activities, including system testing and documentation review
  • Support MES troubleshooting and contribute to continuous improvement initiatives
  • Work cross-functionally with IT and manufacturing teams to ensure efficient MES integration and deployment

Profile Requirements

  • Minimum 3 years of experience as an MES MBR Designer
  • Strong knowledge of PAS-X from Werum is mandatory
  • Background in pharmaceutical or biotech manufacturing environments
  • Experience designing and configuring MBRs/EBRs/gMBRs
  • Understanding of GMP regulations, data integrity principles, and MES best practices
  • Strong problem-solving skills and ability to work independently or as part of a team
  • Based in Ontario, Greater Toronto Area or willing to relocate quickly

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