Intern, NPI & Validation

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.
• The candidate for this role may be employed through a third-party partner of Insulet.
• We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
• At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• ( Know Your Rights )

Benefits

Additional Information

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.

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