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We're looking for people who are determined to make life better for people around the world.
The main function of this position is to support Suzhou factory's process equipment.
The job summary:
1. As a primary frontline person, support on-site work (daily production support)
2. Ensure that from a device and process performance perspective, they meet regulatory and safety requirements
3. Execute fault elimination, deviation investigation and problem-solving, change management, safety evaluation, process monitoring, etc.
Job description:
1. Participate in periodic evaluations of devices
2. Actively participate in safety-related activities and implement HSE and 5S-related measures
3. Promote improved safety status through active participation in safety-related activities (safety audits, workplace safety analysis, hazard assessment, etc.)
4. Support daily maintenance and other related work to ensure system timeliness and reliability
5. Effectively communicate and collaborate with other team members, including production, technical services, quality personnel, and equipment technicians, automation engineers, etc.
A Process Engineer is a device expert and asset custodian for each process team and is responsible for:
- Understanding the safe operating range and special safety requirements of devices, as well as human engineering, exposure, process, and device environmental pollution control requirements
- Understanding operational control strategies and the impact of relevant process parameters on devices
- Knowing and understanding the design basis of devices (user requirements)
- Understanding the quality and energy balance of devices and processes (as applicable)
- Ensuring that first principles are always applied to improve processes and solve problems
- Understanding potential device failure modes and providing recommendations for deviations related to devices
- Understanding device performance (key measurements, measurement uncertainty) and alarm management requirements
- Ensuring a clear understanding of asset performance so that improvement work can be prioritized at the right time (e.g., to improve competitiveness)
A Process Engineer is responsible for confirming the state of the device, such as:
- [...]
- Supporting initial confirmation of devices, developing and approving preventive maintenance plans and spare parts lists, ensuring these are saved in appropriate device management systems
- Ensuring that the confirmed state of the device is properly maintained and monitored throughout its asset lifecycle
- Ensuring that significant changes, maintenance, and other interventions do not adversely affect the confirmed state of the device
- Involving the Engineering Leadership Team in device-related issues, based on suggestions from the process flow team
- Providing guidance on device recovery after intervention
- Having a comprehensive understanding of the process validation process and related devices, facilities, and computer-validated processes
In most cases, a Process Engineer is responsible for variability in process cycle times and production quantities, which includes:
- Identifying process flow bottlenecks, understanding how they are changed and affected by upstream and downstream changes, and providing appropriate improvement measures
- Understanding factors that cause variability in process cycle times and production quantities (common causes or special causes), and suggesting improvements
- Calculating and understanding the main reasons for shutdowns
- Responsible for ensuring device reliability and consistent execution of maintenance strategies
A Process Engineer provides daily production support:
- Using statistical tools to understand and appropriately reduce process variability
- Using historical data and process data resources to extract and plot process parameters
- Leading root cause analysis of device-related issues and providing expertise during investigations
- Responsible for deviation investigation, correction, and prevention, as well as change management
- Guiding and training process flow team members and frontline employees on device understanding and requirements
- Acting as an interface between the Maintenance Team and Public Facilities Team when they do not represent the Process Flow Team
- Ensuring that approved device-related execution documents and instruction manuals can be executed, making actual operations match procedures
- Understanding process health and safety
Basic requirements:
1. Bachelor's degree in engineering (or equivalent work experience)
2. Suitable interpersonal style and communication skills to efficiently work in teams
3. Strong ability to operate computers, able to use various software, including Office and AutoCAD
4. Experience working as a Process Engineer in the pharmaceutical industry
5. Strong problem-solving ability
6. Ability to apply statistical concepts to help solve problems when analyzing production manufacturing issues
7. Experience systematically solving problems using problem-analysis tools