Senior Project Engineer

Responsibilities:

• Responsible for implementing new manufacturing processes.

Key Responsibilities – What will it involve

• Manage project from ideation to production handover
• Is the custodian of the Project's technical success and Project timeline through to complete production handover.
• Ensures an adequate technical team, with all interested parties represented, to progress all aspects of the project.
• Establish URS, Lead & formalize Risk analysis of the project or new equipment
• Manage the project CapEx: Investment request, PR/PO, investments follow-up & reporting, CapEx closure
• Ensures that a realistic project timeline is set up together with all colleagues
• Organizes regular meetings and/or telephone conferences to ensure that the relevant people are kept up to date and that progress is made according to the timeline.
• Lead and/or Approve design (Mechanical, Electrical, Program)
• Ensure smooth making/assembly/construction phases of the project
• Lead FAT/SAT
• Conduct Process validation (DQ/FAT/IQ/OQ/PQ) and write Validation Summary reports
• Responsible for process performance during the production handover and the first months of production.

Qualification:

Education:

• Engineering background. This can be Mechanical, Industrial, or another relevant field of Engineering.

Working experience:

• At least 5 years of experience in technical project management with a focus on implementation/delivering projects/new processes in/for global medical device/pharmaceutical companies

• Knowledge and Experience in Packaging technology are preferred, although the position implies facing and learning new technologies.

• Knowledge of the standards for the Medical Device industry.

• Familiar with the validation flow of new processes (DQ/IQ/OQ/PQ)

Specific skill/knowledge:

• Proficiency in MS Project, Pack Office.

• Experience with CAD Software would be a plus.

General knowledge:

• Strong team player, able to manage people in multidisciplinary teams across different countries

• Creative problem solver

• Accurate, understands data, facts, and figures; can distill complex data into useful information and conclusions.

• Good negotiating skills, able to align the different interests of internal parties Production, Quality, R&D, Regulatory Affairs, Maintenance, Suppliers

• Fluency in English is essential, and fluency in Thai is advantageous

• Self-starter- Capable of working independently and walking on water.

• Combines a hands-on approach with a strategic vision.

• Entrepreneurial skills in terms of problem-solving are key, along with tenacity, toughmindedness, and the ability to influence and demonstrate strong teamwork abilities and commitment.