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.
The candidate for this role may be employed through a third-party partner of Insulet.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
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.