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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 sites 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 RCPTs 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 Managers 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: Bachelors 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 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.