IT Software Engineering Expert - RDT Pharma Medicines
PharmaMedTechQuality Assurancegmpcroinform
Job description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As a Technical Expert within the MES CORE PharmaSuite landscape, you are responsible for driving the technical direction, engineering quality and operational stability of the global MES Platform, Rockwell PharmaSuite.You operate at the intersection of architecture and hands-on engineering, ensuring that solutions are not only well designed but also implementable, stable and compliant in a GxP- regulated environment. You provide technical leadership across multiple solutions , guide teams through complex challenges and act as a senior escalation point for technical critical issues. In this role, you combine strong system design capabilities with deep hands-on expertise in areas such as certificate management, scripting, Kubernetes, and platform operations, while contributing to the technical roadmap and continuous improvement of the MES CORE landscape Description of the area Within RDT Pharma Technical Operations and specifically in the context of Manufacturing Technologies, the Manufacturing Execution System (MES) team is responsible to ensure that our manufacturing operations are running in compliance and efficiently. The MES Technical Lead is the bridge between the high-level business requirements of a manufacturing sites, and the complex technical execution of the software. Job Responsibilities Scope / (Content Leadership): Designs solutions that meet product requirements, business priorities, and enterprise standards. Manages Non-Functional Requirements (NFR) and fitness functions. Documents and evolves the architecture throughout the product life cycle and aligns with the architecture community for governance. Applies frameworks in a Complex or Multiple Solution or Product Context. Accountability/Problem Solving: Leads others to solve complex problems; uses sophisticated analytical thought to exercise judgment and identify innovative solutions. Maintains the vision, roadmap, and current landscape for multiple solutions. Assesses and consults on the impacts and dependencies of initiatives on capabilities, risk, and the application landscape. Creates Conceptual & Logical Data Models, Taxonomies, Ontologies, and Integration pathways for the product. Defines and drives reference architectures, patterns, NFRs, and fitness functions, ensuring Architecture Decision Records (ADRs) are recorded and published for multiple solutions or the product. Drives external technology trends and assesses feasibility, including vendor assessments. Stakeholder Management: Communicates difficult concepts clearly and negotiates with others to adopt a different point of view. Drives information sharing across the complete product. Impact/Strategy: Develops and maintains the product's technology roadmap. Provides technical oversight, guidance, and consultation on specific technologies for product teams. Improves existing solutions, manages technical debt, and researches, evaluates, pilots, and drives the adoption of new technologies. Identifies opportunities to enhance value and business processes within a Complex or Multiple Solution or Product Context. Complexity / (Product Size): Operates within a Complex or Multiple Solution or Product Context. Business / Technical ability: Applies in-depth and expert-level knowledge in multiple technology areas. Proactively contributes to Architecture Practices development and mentoring. Technical Leadership & Engineering: leads the technical design and implementation of MES CORE PharmaSuite components, with a strong focus on: Certificate Management Windows scripting and automation of deployment, configuration and operational tasks Windows and Linux based operating systems in an enterprise environment Containerization and orchestration with Kubernetes Application engineering for PharmaSuite components ( Deployment, configuration, hardening) Expert level troubleshooting and root cause analysis for complex incidents and problems Compliance, CSV & Documentation: ensures that technical solutions and changes comply with GxP, GMP, GAMP5 and Roche Quality Standards, in addition to providing technical input to risk assessments, test strategies and test evidence. Collaborates closely with QA/CSV lead and Delivery Service Manager to ensure consistent and compliant documentation and validation practices across sites. Qualifications Education / Experience Bachelor/master degree in Computer Science, Engineering, Information Systems or a related technical discipline 5+ years of experience in Manufacturing IT and MES Environments, preferablypreferrably with Rockwell PharmaSuite. Demonstrated experience designing business-driven, standards-based, future-ready solutions within a complex or multiple solution/product context. Experience maintaining the vision, roadmap, and current landscape for multiple solutions, and assessing the impacts of initiatives on capabilities, risk, and application landscapes. Proven track record of proactively contributing to architecture practices development and mentoring others. Technical Skills In-depth and expert-level knowledge in multiple technology areas: Windows- and Linux‑based operating systems (installation, configuration, hardening, operations). Windows scripting (PowerShell); experience with Linux Shell Scripting is a plus. Containerization and orchestration with Kubernetes. Certificate management and PKI (provisioning, renewal, deployment, troubleshooting of certificates across environments). Proficiency in creating Conceptual & Logical Data Models, Taxonomies, Ontologies, and Integration pathways for products. Ability to define and drive reference architectures, patterns, NFRs, and fitness functions. Strong troubleshooting skills and hands on experience in application engineering and operations for manufacturing critical systems Additional Qualifications Exceptional communication and negotiation skills, with the ability to communicate difficult concepts and influence stakeholders to adopt different perspectives. Proactive mindset to identify opportunities to enhance value, improve existing solutions, manage technical debt, and lead teams in identifying innovative solutions. <li
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