Intern, NPI & Validation

Job Title:                      Intern, NPI & Validation - Malaysia

Department:                     Plant Engineering, NPI & Validation

Position Overview:

Job Summary

We are seeking a highly motivated and detail-oriented student to join our Validation Team. As a Validation Intern, you will gain hands-on experience in the lifecycle of product design transfer, from test protocol generation to final reporting. You will support the engineering team in ensuring that our [Medical Device OmniPod] products meet strict regulatory requirements and performance specifications. 

Responsibilities:

• Documentation & Protocols: Assist in reviewing and drafting validation life cycle documents, including User Requirements Specifications (URS), Functional Specifications (FS), and Testing Protocols and Report (IQ/OQ/PQ).

• Test Execution: Participate in validation execution on manufacturing equipment/software systems under supervision.

• Data Analysis: Collect, analyze, and document test results to identify functional issues, performance bottlenecks, or deviations from standards.

• Debugging: Participate in troubleshooting issues discovered during validation and conduct root cause analysis (RCA).

• Compliance: Ensure that all activities are performed in compliance with internal procedures, cGMP (current Good Manufacturing Practices) or other relevant industry standards (e.g., ISO, GAMP 5).

• Collaboration: Work with cross-functional teams (ME, QA, Production) to support milestones validation. 

• Automation Support: Contribute to developing test automation tools to improve workflow efficiency.

• Perform other duties as required.

Education and Experience:

• Currently pursuing a Bachelor’s (Electrical, Mechanical, Computer), Biotechnology, Pharmaceutical Science, or related field.

Minimum Requirements:

Preferred Skills and Competencies:

·        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 standard operating procedures (SOPs).

·        Excellent written and verbal communication skills. 

·        Preferably with scripting languages (Python) or SQL for data validation.

·        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.