Siemens Opcenter MES Consultant

Pharmaceutical MES Migration Specialist

Join a dedicated team to support a critical pharmaceutical manufacturing project focused on migrating from an existing Manufacturing Execution System (MES) to Siemens Opcenter. This role requires an expert to adapt production specifications, configure the new system, and ensure full implementation and qualification in strict accordance with site processes and GxP requirements.

Working in a hybrid capacity in Lyon, France, you will collaborate closely with Smart Factory, Production, Quality, and Automation teams. Your primary objective is to ensure that the MES configuration aligns perfectly with site production processes while maintaining compliance with applicable pharmaceutical and GxP standards.

Key Responsibilities

MES Configuration & Setup

• Adapt existing MES specifications for the new MES environment.
• Configure production workflows, including electronic recipes and master data.
• Configure quality control points and associated alerts.
• Configure equipment connected to the MES.
• Support the migration from the existing MES environment to the new MES.

Testing & Qualification

• Perform dry runs.
• Execute IQ activities in pre-production and production environments.
• Write and execute IQ/OQ/PQ test protocols.
• Perform test runs to resolve deviations and complete qualification activities.
• Prepare qualification reports.

Required Experience

• Strong hands-on experience with Siemens Opcenter MES.
• Experience with MES configuration and implementation.
• Experience with MES migration projects, particularly migration from an existing MES to a new MES environment.
• Hands-on experience with production workflows, electronic recipes and master data.
• Experience with MES qualification and validation in a pharmaceutical/GxP environment.
• Good knowledge of IQ/OQ/PQ and pharmaceutical validation processes.
• Experience working with Production, Quality, Automation and Smart Factory teams.
• Ability to analyse existing MES specifications and adapt them to a new MES environment.
• Strong documentation and communication skills.
• Fluency in French and English.