Intern, NPI & Validation Engineering
On-site · Gelang Patah, Johor, Malaysia
Job Summary
Intern, NPI & Validation Engineering role in Malaysia. Support the Validation Team across the product design transfer lifecycle from test protocol generation to final reporting for the Omnipod medical device. Responsibilities include reviewing and drafting validation life cycle documents (URS, FS, IQ/OQ/PQ), participating in validation execution on manufacturing equipment/software, collecting and analyzing test data, performing root-cause analysis, ensuring compliance with cGMP and relevant standards (ISO, GAMP 5), collaborating with ME/QA/Production, and contributing to test automation efforts. Ideal candidates are currently pursuing a Bachelor’s degree in Electrical, Mechanical, Computer, Biotechnology, Pharmaceutical Science, or related field with exposure to validation methodologies, medical device quality principles, Python/SQL scripting, and familiarity with lab equipment.
Required Qualifications
- Currently pursuing a Bachelor’s degree in Electrical, Mechanical, Computer, Biotechnology, Pharmaceutical Science, or related field.
- Basic understanding of validation methodologies and medical device quality principles.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- Strong attention to detail and ability to follow strict SOPs.
- Familiarity with lab equipment (e.g., oscilloscopes, multimeters) or manufacturing systems.
- Basic understanding of Medical Device regulations involved GAMP 5, 21 CFR Part 11, or ICH guidelines.
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