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The Position

Job Summary:

The job holder will be a technical leader and SME for level 2 computerized automation system of equipment of facility and utility which support production asset. He or She will be the asset owner to execute Asset lifecycle management for infrastructure within automation network. He or She needs to take care of lifecycle management of related database, web, App and communication protocol.

The job holder will lead or support new project for automation infrastructure upgrading, VM migration, Web development and launch etc.

Leads and manages an Operation Technology Engineering team for assigned operating unit within Dept. Manages and allocates team resources (FTE,BPO and 3rd Party) for projects involving technical research and development engineering to support the assigned automation and digitalization strategy in accordance with current Good Manufacturing Practices (cGMP) requirements and Roche corporate standards. Responsibilities may include engineering and operations support for operational efficiencies, process and technology improvements for pilot technology introduction within RDSZ and/or leading other projects to deliver critical efficiencies and innovative processing technologies

With team, acts as design consultants for new and continuous improvement of existing processes, technologies and equipment from OT perspective. Which tracks the overall project commitments and project performance metrics within the organization. Ensures effective management and forecasting of resource commitments and a best practices forum for project management and cost controls.

Oversees, reviews and approves scope of work definitions and ensures effective management of employees and any contractors for assigned projects. Selects, develops and evaluates employees to ensure the efficient operation of the function.

As a team leader, fully apply the leadership requirement of Roche starts from VACC for effective management of entire team members.

The Opportunity:

• Ensure all the automation Level 2 related tasks are in compliance including quality and security.
• As technical SME of automation Level 2, responsible for define and keep optimizing the PM task
  of F&U automation infrastructure (Blade server, switch, AP, rack, power feeding, etc)
• Responsible for complex automation Level 2 problem solving of F&U system, lead automation Level 2 modification and improvement of relevant F&U system
• Responsible for automation Level 2 system maintenance, including but not limited to database backup and recovery, software system diagnosis and maintenance
• Lead or support for the new automated process system project from procurement, installation, validation, calibration, and maintenance
• Technical training for F&U technicians.
• Participate in the design and implementation of new automation system or infrastructure according to divisional and local standards.
• Support or lead improvement or CAPEX from commissioning to qualification (SAT/FAT/IQ/ OQ/PQ). (SAT/FAT/IQ/ OQ/PQ)。 Lead and Drive RDSZ to complete automation digitalization transformation which match with Roche strategy.
• Other tasks assigned by head of department

Who You Are:

• Technical education background, major in automation or information technology engineering
• Bachelor or above education background
• Automation and information technology education or equivalent by experience
• > 5 years working experience in a high regulated manufacturing site
• Familiar with problem solving methods
• Web development based on IIS
• Strong Automation background
• New system qualification and validation experience is a plus
• Experience in a highly regulated cGMP manufacturing environment.
• Basic SHE ergonomics concept
• Familiar with CFDA Medical Device GMP
• Familiar with information technology and automation principles, understanding of hardware and software design
• Knowledgeable in common of PLC and IPC- Hardware/Software such as STEP7, Portal, Zenon, WinCC.
• Familiar with Cisco network and configuration
• Project management skills
• Good understanding of the commissioning and qualification process and activities
• Familiar with VMware and know how to manage Virtual machine
• Master SQL database management
• Master usage of C# for coding work
• A “can-do” attitude and willingness to go the extra mile when required
• Experiences in risk assessments such as PFMEA methodology
• Knowledge of VMware is preferred
• Knowledge of Kepware is preferred
• Knowledge of IBA is preferred
• Knowledge of Web Wincc is preferred

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.