Job Description
About the role
Job Title: Validation Engineer
Works closely with and have impact on: Production, Quality assurance, SCM, ME
Reports to: Head of department.
Function: Production Engineer.
Work Location/Site: Thailand
Role Overview
This position is responsible for production validation activity including capacity expansion, innovation, and process improvement. He or She will be CCR owner to responsible from CR initiation until implementation to mass production.
Duties and Responsibilities
- [1] To conduct client validation activity as per assignment. To be an owner of Change request from initiate the change until implementation to mass production. The scope will cover capacity expansion, innovation, and process improvements.
- [2] To conduct engineering test, technical preparation and reports relates to the change.
- [3] Assist in writing and updating procedures or work instruction to ensure efficiency, standardization, and accuracy.
- [4] To conduct or support improvement testing/problem solving testing.
[5] Support of non-conformation product management to prevent escape/overkill judgment by request. Co-operation with sustaining engineer team or relevant department of each NC product ex. QA, QLab or SCM to prevent overlook of quality measurement and release to sale date.
[6] Comply and adhere to the Regulatory, Quality and Environment-Health-Safety requirement.
[7] To be assigned work as required by superior.
Requirements
Experience
- 1 to 5 years of working experience in validated company, process control or improvement manufacturing.
- Experience in medical device and ISO13585 is preferred or related requirement.
- Math skills, analytical skills, teamwork, familiarity with Basic software and field specific software such as Minitab.
Skills/Accreditations
- Good leadership, human relation, and accountability
- Positive attitude, good communications, and interpersonal skills.
- Good in written communication and presentation skills. Good command in spoken and written English.
- Logical thinking, analytical skills, teamwork, familiarity with Basic software.
- Demonstrated problem solving and leadership skills.
- Process and detail oriented, including strong interpersonal and prioritization skills.
- Lean manufacturing experience with a continuous improvement mindset.
- Highly motivated to work in a dynamic environment, with good integrity and character.
- Ability to multi-task and organize work systematically in meeting deadlines without compromising.
- Good teamwork, well understanding of production and cleanroom environment control.
Academic Qualifications
- Background in Engineering, Science or Health (either industrial engineering, system engineering, chemical, food science, pharmaceutical)
