MES Configuration Expert - Opcenter Execution Pharma

About The Job

The MES Digital Configuration Expert contributes to the design, build, and lifecycle of Sanofi's global end-to-end MES solutions (Siemens Opcenter Execution Pharma), guided by the MES Digital Configuration Lead, and ensures local configurations align with the Core model and operational excellence standards while guaranteeing the right usage of Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments.

The role

• Guarantees and promotes the right usage of Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments

• Leverages the Digital Portfolio's Detail Design documents, catalogue of services, and existing Core building blocks

• Supports sites in troubleshooting and remediation action plans

• Works closely with MES Product Owners, MES Configuration Experts/Leads, MBR Developers, MES installers/developers, Product lines, local digital teams, Business Process Owners, Archetype leads, Site modelers, and Shopfloor experts

• Remains current on company standards, Digital industry practices, and emerging standards, while contributing to Digital standards maintenance

• The profile is primarily Siemens Opcenter Execution Pharma-oriented, with strong adaptability expected toward evolving Digital industry practices and standards.

Business Processes In Scope

• Main MES System: Siemens Opcenter Execution Pharma

• Master Data Management (items, user rights, equipment, locations, work orders)

• Master Batch Record design & approval (including workflows)

• Master Batch Record review & approval (by Exception)

• Production Execution

• Weighing & Dispensing

• Communication to Equipment / SCADA systems

• Equipment Management

• Material Flow Management

• Traceability / Genealogy

• Labelling

• Reporting

• Integration with ERP, LIMS, Documentation, Deviation Management, Serialization, eOEE, and shopfloor systems

Key Responsibilities

• Business Alignment & Core Model

• Understand business requirements (including analytics) for various processes, challenge, consolidate, and extrapolate them to design & build solutions expandable to multi-business unit use cases and plant configurations

• Maximize customer satisfaction while minimizing build and maintenance costs and risks associated with fulfillment of business needs

• Implement appropriate services to ensure optimal allocation of all available capabilities

• Evaluate impact analysis of solution options and assess/manage associated risks

• Conduct end-to-end business process analysis including integration with partner systems (ERP, shopfloor systems, automation layers), labelling technologies, and mobile technologies

• Technical Leadership & Problem Solving

• Provide functional & technical support during the full solution lifecycle and to the sites

• Participate in regular design reviews with site modelers to ensure best practices are followed

• Perform or participate in regular MBR reviews for sites

• Manage incidents & corrective/preventive actions

• Manage preventive/corrective maintenance for components

• Ensure technical solutions comply with recommendations for Quality, Security, and Accessibility

Delivery & Quality

• Design and build MBRs, Process Instructions, blocks, and templates including Functional specifications

• Configure & implement core solutions as close to standard market solutions as possible, based on state-of-the-art best practices

• Aim to align processes and enable industrial efficiency across different Sanofi industrial sites

• Define appropriate design & build of solutions by adopting GxP validations

• Lead the on-time delivery of projects while ensuring robust, cost-effective solutions

• Safeguard proper deployment of core solutions on different industrial sites

• Participate in defining indicators for performance and quality of service, monitor and communicate them

• Ensure standards and rules for Platform Management (Release management, Solution Documentation, Testing) are correctly understood and applied

People & Knowledge

• Coordinate, inform, and ensure functional expertise in a matrix context

• Transfer know-how, experience, and best practices to sites

• Contribute to Digital skills development within your domain

• Ensure adoption and adequate use of solutions

• Deliver on-site training to manufacturing sites

Strategy & Innovation

• Remain current on technology trends and benchmark with other companies and partners to bring innovative inputs to solutions, operating models, and strategy

• Collaborate with peers (Enterprise Architects, solution/technical architects, Quality, Cybersecurity) to review and qualify solution design and/or introduction of new technology

• Explain/present architecture and technical matters in an understandable way to Digital management team, staff, and business stakeholders

• Break current GxP Validation established postulates to simplify and adapt to current and next-generation technologies & methodologies (Cloud, Service Management, Agile)

About You

Experience

• 5+ years of work experience in Digital for Manufacturing domain, ideally with experience in MES, specifically Siemens Opcenter Execution Pharma

• Demonstrated experience in multicultural/multilanguage environments and matrixed organizations

• Broad knowledge of manufacturing processes in industrial plants

• Strong MES experience: market standards knowledge (solutions, technologies, integration, architecture), process industry within life science/pharmaceutical industries

• Experience & understanding of core product/model concept

• Successful and significant Project Management experience is a plus

Technical Skills

• Expertise in MES solutions: Siemens Opcenter Execution Pharma — Required

• Strong knowledge of Manufacturing Execution Systems, including Master Batch Record and Review by Exception business processes

• Solid understanding of manufacturing processes in pharmaceutical plants

• Strong knowledge of pharma industry regulatory context (GxP)

• Strong knowledge of Digital technologies & concepts

• Knowledge of Automation layer (SCADA, DCS, PLCs, industrial protocols)

• Knowledge of Scripting (VB/.Net) development & validation

• Knowledge of Werum PAS-X (Körber) is a plus

• Knowledge of Opstrakker (elogbook/eforms) is a plus

• JSON development is a plus

• Knowledge of reporting tools (Power BI) is a plus

• Low-code application development using Mendix is a plus

• AI-assisted MES solution development using GitHub Copilot, Claude, Microsoft Copilot is a plus

• Cloud architecture & services knowledge (Azure preferred) is a plus

Soft Skills

• Accountability and reliability

• Customer-driven mindset

• Fast learner, proactive, willing to apply change management

• Ability to deal with ambiguous situations

• Strong focus on value delivery, with ability to work autonomously on solution design

• Ownership and leadership within assigned scope

• Agile methodology practitioner

• Communication and interaction skills

• Ability to challenge, open-minded and active listening

• Ability to explain complex matters in a simple and understandable way

Education & Languages

• Engineering degree or Master's in Computer Science or related field (or equivalent experience)

• English — mandatory | Other languages are a plus

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