Responsibilities: 

• Manage/perform process validation activities which includes capacity expansion, line/equipment transfer, process improvement, local equipment relocation.
• Manage/perform cleanroom, utilities or system validation.
• To maintain validated processes via annual review of validation or revalidation, also to review/evaluate/approve changes on existing manufacturing documents that might affects validity of processes such as work instructions, etc.
• Resolve quality issues related to existing validated processes, handle NCRs and CAPAs, and provide technical or validation support plus problem solving. 
• Support all types of audits such as IQA, ISO, FDA, etc. 

Requirements:

• Bachelor degree in Engineering Mechanical / Science or equivalent.
• Have at least 2 years of related working experience, preferably Medical Device Industry.
• Have strong technical and problem-solving skills to ensure optimal project execution and implementation.
• Knowledgeable on effective and efficient product manufacturing processes.
• Have strong communication skills, proficient in written and spoken English.
• Able to work independently, be structured and systematic. Able to work in a cross-cultural team.
• Understand documentation work is part of work nature.
• Must have a sense of urgency and commitment to project schedules.
• See it as a challenge to work in a dynamic international environment.
• It will be an advantage to have relevant experience from the Medical Device industry including FDA requirements, Design Control, Process Validation and ISO 13485.