MES Configuration Expert Opcenter Execution Pharma

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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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

The salary range for this position is :€49,600.00 - €74,400.00 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.