RCPT MES system owner at F. Hoffmann-La Roche Ltd - Poland

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

12 Mar, 26

Salary

0.0

Posted On

12 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Rockwell PharmaSuite, GxP Compliance, Project Leadership, Technical Expertise, System Validation, Data Integrity, SQL Server, Integration, Change Control, Stakeholder Management, Operational Excellence, Database Management, Manufacturing Processes, Training, Continuous Improvement, Communication Skills

Industry

Biotechnology Research

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 Overview The RCPT MES PharmaSuite System Owner will be the primary technical and functional leader responsible for the successful implementation, validation, and ongoing operational support of the Rockwell MES PharmaSuite system at the RCPT (Roche China Pharmaceutical Technology) plant site. This role requires deep technical expertise in the Rockwell PharmaSuite product, strong project leadership skills, and a comprehensive understanding of GxP pharmaceutical manufacturing processes and their critical impact on business operations. The System Owner will serve as the technical deputy to the Project Manager during implementation and will assume full ownership of the system following the Go-Live phase. Key Responsibilities Implementation and Project Leadership (Pre-Go-Live) Technical Authority: Serve as the site's primary technical expert on the Rockwell PharmaSuite MES application, configuration, and architecture. Solution Design Review: Work closely with the Project Manager, Roche Global PS Core Team, and implementation partners to review and approve all critical technical solution designs, ensuring they meet RCPT's business requirements, GxP compliance standards, and global Roche MES templates. Impact Assessment: Analyze the technical solution and configuration changes for potential impact on business operations, data integrity, and compliance. Proactively mitigate risks. Implementation Support: Provide hands-on technical guidance and support to the site implementation team, including configuration, testing, data migration, and integration activities (e.g., ERP, Automation/SCADA). Project Deputy Role: Act as the Project Manager's deputy, taking the lead on technical workstreams, driving site-specific implementation tasks, and representing the site in global technical forums. Validation Support: Support the Computer System Validation (CSV) effort by contributing to the generation and execution of validation documentation (e.g., IQ, OQ, PQ) and ensuring the system is validated according to regulatory requirements. Training and Handover: Plan and execute technical knowledge transfer to the site operations and IT support teams in preparation for Go-Live. System Ownership and Operations (Post-Go-Live) System Lifecycle Management: Be accountable for the overall health, performance, security, and maintenance of the PharmaSuite MES system at the RCPT site. Operational Excellence: Oversee daily system operations, troubleshoot complex issues, and manage escalation processes with global support teams and vendors (Rockwell). Change Control and Maintenance: Manage all system changes, enhancements, and upgrades via the established change control process, ensuring compliance with GxP regulations. This includes reviewing and approving technical specifications, test plans, and deployment strategies. Regulatory Compliance: Ensure the system maintains its validated state and adheres to all relevant regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). Manage periodic reviews and audit readiness activities. Stakeholder Management: Serve as the key liaison between RCPT Manufacturing, Quality, IT, and the Global PharmaSuite Core Team for all system-related matters. Continuous Improvement: Identify and propose system improvements and optimizations to enhance manufacturing efficiency, quality, and data capture capabilities. Required Technical Knowledge and Experience Rockwell PharmaSuite Expertise Deep Product Knowledge: Extensive hands-on experience with the Rockwell PharmaSuite MES platform, including its core modules: Electronic Batch Record (EBR), Weigh & Dispense, Equipment Management, and Material Management. Configuration: Proven ability to configure complex master data within PharmaSuite (e.g., Recipe definitions, User Security, Workflows, Equipment definitions). Architecture: Solid understanding of the PharmaSuite technical architecture, including client-server components, database structure (SQL Server preferred), and virtualized environments. Integration: Experience integrating PharmaSuite with other enterprise systems, particularly ERP (e.g., SAP) and Automation/Control Systems (e.g., SCADA, PLC). Knowledge of common integration technologies (e.g., interfaces, web services, OPC). Reporting and Data: Experience with data extraction, reporting tools, and ensuring data integrity within the PharmaSuite environment. General Technical Skills Database Management: Proficiency in SQL and experience working with SQL Server databases as they relate to MES data. IT Infrastructure: Basic understanding of networking, operating systems (Windows Server), and cybersecurity principles relevant to manufacturing systems. Qualification and Experience 能力与经验 Qualifications Education: Bachelor's degree in Computer Science, Engineering, or a related technical field. Experience: Minimum of 5-7 years of experience in IT or Automation roles within the Pharmaceutical or Biotechnology industry. MES Specific: At least 3-5 years of direct, hands-on experience with the Rockwell PharmaSuite MES system, covering both implementation and support phases. Compliance: Strong knowledge of GxP, FDA, and international regulatory requirements for computerized systems in a validated manufacturing environment. Project Skills: Proven ability to lead technical workstreams, manage complex tasks, and act as a deputy project lead. Soft Skills: Excellent communication, influencing, and stakeholder management skills. Ability to translate technical requirements into business impacts and vice-versa. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The RCPT MES PharmaSuite System Owner will lead the implementation, validation, and operational support of the Rockwell MES PharmaSuite system. They will serve as the primary technical expert and manage system lifecycle, ensuring compliance and operational excellence post-Go-Live.