MES DevOps Engineer - Werum PasX & Opstrakker

About the job

• Company Context
• Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value.
• The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance.
• Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & full MES), with a second wave currently in motion. This represents a strategic opportunity for Manufacturing & Supply Transformation to:
• Design standardized end-to-end processes to generate business value and deliver best-in-class solutions to industrial sites, with high focus on electronic batch record management & review by exception process
• Deliver innovative "state of the art" tools enabling performance for manufacturing processes
• Allow new generation of deployment – more Agile & business centric
• Maintain robust and highly available solutions to operate industrial processes efficiently

• Role Overview
• The Manufacturing Execution System (MES) DevOps Engineer drives the design, build, and lifecycle of global end-to-end MES solutions. You will ensure local configurations align with the Core model and operational excellence standards while guaranteeing and promoting the right usage of Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments.
• You will leverage the Digital Portfolio's Detail Design documents, catalogue of services, and existing Core building blocks while supporting sites in troubleshooting and remediation action plans. Working in close collaboration with MES Product Owners, MES DevOps Manager, MBR Developer, MES Full Stack Engineers, MES installers/developers, Product lines, local digital teams, Business Process Owners, Archetype leads, Site modelers, and Shopfloor experts, you will remain current on company standards, Digital industry practices, and emerging standards while contributing to Digital standards maintenance.

• Systems & Processes in Scope
• Main MES Systems:
• Werum Pas-X MES Product (Korber) & Opstrakker (elogbook/ eforms)
• Business Processes Covered:
• Master data management (items, user rights, equipment, locations, work orders)
• Master batch record design & approval (including workflows)
• Master batch record review & approval (by Exception)
• Templates for elogbook (Opstrakker)
• Production execution
• Weighing & Dispensing
• Communication to equipment or SCADA systems
• Equipment management
• Material flow management
• Traceability / Genealogy
• Labelling
• Reporting
• Interface with ERP, quality, logistics & shopfloor systems (LIMS, Documentation, Deviation management, Serialization, eOEE)

• Key Responsibilities
• Business Alignment
• 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

• Stakeholder Management & Training
• 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
• Provide functional & technical support during the full solution lifecycle and to the sites
• Ensure adoption and adequate use of solutions
• Deliver on-site training to manufacturing sites

• Delivery & Quality of Services
• 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
• Participate in regular design reviews with site modelers to ensure best practices are followed
• Perform or participate in regular MBR reviews for sites
• Ensure technical solutions comply with recommendations for Quality, Security, and Accessibility
• 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
• Manage preventive/corrective maintenance for components
• Ensure standards and rules for Platform Management (Release management, Solution Documentation, Testing) are correctly understood and applied
• Manage incidents & corrective/preventive actions
• Strategy Development & Implementation
• 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 & Knowledge

• 8+ years of work experience in Digital for Manufacturing domain, with 5+ years of experience in MES, specifically Werum Pas-X and Opstrakker (elogbook/ eforms)
• 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: Werum Pas-X (Korber) and Opstrakker (elogbook/ eforms)
• 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
• JSON development is a plus
• Knowledge of reporting tools (Power BI) 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
• Engineering degree or Master's in Computer Science or related field (or equivalent experience)
• Language
• Fluent in English, other languages are a plus
• Working Environment
• Travel requirement: 30% of time to manufacturing sites in Europe, North America & Asia
• Global, matrix organization environment
• Must be able to work effectively across different time zones and cultures

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, disability, or gender identity.

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