[ PD ] - Senior Automation Engineer (Process Engineering)

Main Responsibilities

• Cross-functional leader role interacting with various departments, internal stakeholders and suppliers.
• Establish and maintain appropriate project governance to ensure communication, flow of information and documentation within the project.
• Responsible for project deliverables, schedule, cost and quality as well as management reporting.
• Review schedule with supplier and project team.
• Organize project kick-off, concept review, design review and project status update meeting.
• Follow up on action items of project meeting.
• Proactively identify and manage the risks of project and escalate according to project escalation level.
• Follow company procedure to improve and author User Requirement Specification of process equipment for purchasing. The content must cover technical necessity and general specification to meet medical device manufacturer’s industrial criteria.
• Ensure that machine specifications are correct, complete, feasible and efficient.
• Monitor and ensure engineering design and documentation are on time and complete.
• Executing the design review with external (FAAM) Fully Automated Assembly Machine suppliers for process layout design, process optimization and equipment development.
• Suggest or provide solutions when a deviation occurs.
• General technical methodology/proposal alignment with relevant stakeholder departments (Risk Department, Validation Department, Project Management Department, Quality Department).
• Responsible to follow the principle of GMPs.
• Review Documentation such as Functional Specification (FS), Hardware & Software Design Specification, …
• Support the complete project lifecycle such as Process Integration, FAT & SAT with supplier.
• Review and schedule machine test and review test results.
• Consult engineers to execute, monitor process related activities.

Required Skills & Qualifications

• Degree in Mechanical Engineering
• 5+ years of relevant industry experience in Automation and mechanical design
• SolidWorks or GOM Inspect or Pro/E AutoCAD or CNC machining.
• Good command of English reading, writing and communication ability