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Main Tasks & Responsibilities主要工作职责 :
General Job description and scope
The RCPT Integration Layer System Owner will be the primary ITOT leader responsible for the successful implementation, validation, and ongoing operational support of the Aveva Data Historian PI system, Rockwell Scada System, GMP File Transfer systems and Smart Manufacturing (MQTT) at the RCPT (Roche China Pharmaceutical Technology) plant site. This role requires strong leadership skill, business analyst capability in the Pharmaceutical manufacturing area, deep technical expertise in the integration layer sitting in lv2/2.5 (SA95 model) 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 Project Leader during implementation and will assume full ownership of the system following the Go-Live phase.
Project / Taskforce / Squad Leading: Serve as the site's primary IT system owner on the automation topics: business requirement analysis, backlog prioritization,architecture design, IT automation (SCADA, MQTT, PI, file transfer) release plan, system & function design, installation, testing and interface to other IT systems (e.g. MES ) and process equipment with equipment vendor’s support.
Play as the leader to drive the cross functional team (ITOT, foundation IT, Roche Business and local external supplier) in various locations (SHA, KL, KAU & MAD) to achieve the defined tasks
Taking the lead on technical workstreams, driving site-specific implementation tasks, and representing the site in global technical forums. Build the project team capability to follow the RCPT quality governance and Roche project management guidance to deliver IT automation solution to RCPT.
Solution Design Review: Work closely with the Roche Digital Technology (RDT) Global IT automation product Team to define the proper digital solution align with RDT strategy and solution pool. Have a strong technical capability to understand digital automation solution in China from external partners.
Work as IT solution local decision person to review and approve all critical technical solution designs, ensuring they meet RCPT's business requirements, GxP compliance standards, and global RDT templates.
Drive the technical solution and reach the agreement with the full alignment with business team and technical team
Implementation Support to other Streams: Provide hands-on technical guidance and support to other site implementation team (e.g., ERP, MES, Serialization, QC lab and Automation), including configuration, testing, data migration, and integration activities
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.
Stakeholder Management: Strong business analyst with solid technical knowledge in Automation and IT system integration to serve as the area business partner with strategic thinking for RCPT Manufacturing, Quality, Warehouse, and F&E.
Deeply understand the business process and needs behind, drive the ideation discussion, influence the key stakeholders with a most suitable digital & business solution, lead the technical feasibility study, propose the solution following business strategy and RDT / ITOT digitalization strategy to meet the business sustainability and compliance requirements.
Manage system enhancements based on the business priority and resource capacity.
Provide the workaround from existing system functionality.
Or other Continuous Improvement opportunities for efficiency, quality, and data capture capabilities.
System Lifecycle Management & Change Control Maintenance: Be accountable for the overall health, performance, security, and maintenance of the IT automation and integration system at the RCPT site.
Lead the taskforce team / Squad to 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.
Operational Excellence: Oversee daily system operations, troubleshoot complex issues, and manage escalation processes with global support teams and automation solution vendors to follow the business running shift.
Co-own business goal,e.g. RFT, OLT, OEE, to ensure the stability system operation and minimize the interruption to the business Make, Access and Release
Primary role in IT to interface inspection and audit activities: Ensure the system maintains its validated state and adheres to all relevant regulatory requirements (e.g., FDA 21 CFR Part 11, GxP). Manage all kinds IT lifecycle operation check for example, periodic reviews, DR, BCP and audit readiness activities.
Leadership Skill:
Strategic Vision & Influence: Ability to define the technical roadmap for IT automation and integration at RCPT, align it with global ITOT strategy, and influence key business and IT stakeholders to drive adoption and compliance. Drive cross-functional alignment and decision-making in a GxP environment.
Accountability & Ownership: Demonstrated history of taking end-to-end ownership for IT automation and integration systems, including performance, compliance, and lifecycle management. Ability to lead incident response and critical problem resolution under pressure.
Team & Stakeholder Leadership: Experience leading technical teams (internal staff, contractors, or vendors) and managing diverse stakeholders (Manufacturing, Quality and RDT Global Teams). Strong ability to mentor technical talent and drive results through others.
Communication: Exceptional verbal and written communication skills (in English and Mandarin) necessary to articulate complex technical issues to non-technical business leaders and to represent the site in global forums.
Deep Product Knowledge: Extensive hands-on experience with IT automation and integration, including products used in Roche manufacturing network: Aveva PI, Rockwell / Siemens SCADA, MQTT message broker implementation experience in pharmaceutical manufacturing operation. Understand the design of complex configuration (e.g., master data definitions, User Security, Workflows, Equipment tag, logic calculation definitions).
Architecture: Solid understanding of MES system technical architecture, SA95, SA88 and 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.
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.
2. Qualification and Experience 能力与经验
Education: Bachelor's degree in Computer Science, Engineering, or a related technical field.
Experience: Minimum of 10 years of experience in IT or Automation roles within the Pharmaceutical or Biotechnology industry with GXP experience
Automation and IT manufacturing technical Specific: At least 7 years of direct, hands-on experience with the manufacturing digital solution (MES, SAP, DHS PI, manufacturing integration,e.g. SCADA, MQTT and process equipment) in Pharmaceutical MAKE, Access, Release processes, covering both implementation and support phases.
Understand the data flow integration including equipment, automation system, manufacturing IT systems and interface in between.
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.
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.