Specialist DDIT OPS Mfg Site OT Engineer

Job Description

The role is responsible for the integration of new process equipment in addition to maintaining, troubleshooting, and modifying existing GMP and non-GMP control systems for a GMP Radioligand Therapies Production Facility. Systems at the Haiyan Site include plant wide SCADA, 3rd party skid and stand-alone control systems, freezers, air handlers, chillers, and Building Management Systems.

Key responsibilities

• Oversee and manage production system control, ensuring smooth and efficient operations.
• Handle and resolve production-related issues promptly to minimize downtime.
• Provide technical expertise for the design, configuration, installation, and maintenance of IT Systems software and associated hardware; including interacting with other teams as necessary.
• Manage and control the upgrade, optimization, and iteration of production systems.
• Oversee release management, ensuring timely and accurate deployment of updates and new features.
• Develop and implement policies and procedures to enhance production control processes. Monitor production performance and adjust schedules as necessary to meet demand.
• Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware, including interacting with other teams as necessary.
• Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant DCS, EMS and BMS systems, data concentration, batch reporting, and data retention.

• Support site-based project execution and excellent operations.
• Prepare scopes of work and lead automation contractors as required to complete required work within project timelines.
• Develop project objectives working with user requirements and business plans.
• Determine equipment or system specifications and most cost-effective technology to be implemented.
• Leading in discussions with internal business partners on priorities and timelines, consistently supporting the transparent sharing of information.
• Develop equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
• Participate in operational excellence and continuous improvement efforts.
• Problem solve any technically related issues impacting production.
• Create and update procedures to drive operational efficiency and compliance.
• Implement and revise SOPs to conform with standards and policies.

Minimum Requirements

• Full-time university diploma and major in electrical engineering/automation or equivalent.
• Minimum of 6 years of experience in Automation, Minimum of 3 years in a GMP Pharma environment.
• Technical Skills with industrial Ethernet, Internet of Things, PLC, SCADA，DCS. Preferred SCADA is Zenon.
• Experience with EMS and BMS, Sauter EMB and BMS is Preferred.
• Knowledge of communication protocol. Such as TCP/IP, MODBUS, OPC, etc.
• Experience with writing SQL-based applications (MySQL/MS SQL).
• Computer system validation experience, be able to write CSV document.
• Good communication with internal team and Global supporting team.
• Effective communication skills both verbal and written in Chinese and English, seamless.
• Hands-on experience building, fixing and troubleshooting things using common hand tools and diagnostic tools.
• Be able to maintain the lifecycle of automation system to ensure high quality computer system including implementing changes or resolve system issues.
• Proven experience in managing budgets and project pipelines.