Mission Overview
The consultant will handle OPEX (routine) activities to maintain MES operability in the production building and drive continuous improvement.
Main Responsibilities
• Collaborate with production and quality teams to prioritize modifications in gMBRs and related documentation.
• Create and structure system documentation (SOPs specifications).
• Support version upgrades of MBRs (update qualification docs: Visio FS UATC SOPs specs etc.).
• Modify MBR designs according to user needs.
• Perform IQs and assist during UAT execution.
• Investigate and resolve anomalies found during IQ/UAT.
• Manage and update Master Data (e.g. equipment data).
• Handle Quality System activities (Change Control Deviations CAPA) — lead investigations and improvement actions.
• Provide user support: create/update training materials and deliver training sessions.
• Manage system incidents and coordinate complex investigations with local & central digital teams (AIMS support).
• Manage user accounts and ensure proper MES training compliance.
• Participate in periodic system reviews and maintain validated status.
• Coordinate incident ticket handling for interfaces.
• Assess project impacts on MES and ensure operational continuity.
• Support business users in managing MES applications.
• Analyze trends in exceptions with production and quality.
• Deliver monthly activity reports on time.
• Provide MES on-call support for the production building.
What We’re Looking For
• Strong experience with Werum PAS-X (design configuration testing and support).
• Background in pharma or production environments.
• Experience in MBR creation/modification validation (IQ/UAT) and user support.
• Fluent in English and/or French.
Mission Overview The consultant will handle OPEX (routine) activities to maintain MES operability in the production building and drive continuous improvement. Main Responsibilities • Collaborate with production and quality teams to prioritize modifications in gMBRs and related documentatio...
Mission Overview
The consultant will handle OPEX (routine) activities to maintain MES operability in the production building and drive continuous improvement.
Main Responsibilities
• Collaborate with production and quality teams to prioritize modifications in gMBRs and related documentation.
• Create and structure system documentation (SOPs specifications).
• Support version upgrades of MBRs (update qualification docs: Visio FS UATC SOPs specs etc.).
• Modify MBR designs according to user needs.
• Perform IQs and assist during UAT execution.
• Investigate and resolve anomalies found during IQ/UAT.
• Manage and update Master Data (e.g. equipment data).
• Handle Quality System activities (Change Control Deviations CAPA) — lead investigations and improvement actions.
• Provide user support: create/update training materials and deliver training sessions.
• Manage system incidents and coordinate complex investigations with local & central digital teams (AIMS support).
• Manage user accounts and ensure proper MES training compliance.
• Participate in periodic system reviews and maintain validated status.
• Coordinate incident ticket handling for interfaces.
• Assess project impacts on MES and ensure operational continuity.
• Support business users in managing MES applications.
• Analyze trends in exceptions with production and quality.
• Deliver monthly activity reports on time.
• Provide MES on-call support for the production building.
What We’re Looking For
• Strong experience with Werum PAS-X (design configuration testing and support).
• Background in pharma or production environments.
• Experience in MBR creation/modification validation (IQ/UAT) and user support.
• Fluent in English and/or French.
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