Senior / Staff NPI Engineer (Process Validation)
Country:
Malaysia
Location:
Penang, MY
City:
Penang
Business Area:
R&D
Employment type:
Full-time
Responsibilities:
- Lead and/or participate in establishing validation strategy and scope for new production line set up and design changes.
- Accountable for process validation activities which includes creating protocols, executing tests and compiling reports.
- Support activities on defining process requirements for validation, plus the test methods.
- Collaborate with project stakeholders to ensure process validation are carried out effectively and successfully to meet project objectives.
- Resolve quality issues related to new and existing products, including handle NCRs and CAPAs.
- Execute / support assigned tasks including provide technical or engineering support plus problem solving.
Requirements:
- A degree in Engineering Mechanical / Mechatronics Engineering or equivalent.
- Have at least 5 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 manufacturing processes, equipment, tests and process validation.
- 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.