NPI & Validation Intern

4w4 weeks ago

Insulet Corporation

MY · Full-time · MYR 1,000 – MYR 2,000/mo

About this role

We are seeking a highly motivated and detail-oriented student to join our Validation Team, supporting the lifecycle of medical device product design transfer. This hands-on internship focuses on ensuring that OmniPod products meet strict regulatory requirements and performance specifications.

Daily activities involve reviewing and drafting validation life cycle documents including User Requirements Specifications, Functional Specifications, and Testing Protocols (IQ/OQ/PQ). You will participate in test execution on manufacturing equipment and software systems while collecting and analyzing data to identify functional issues or deviations.

The role works closely with cross-functional teams across Mechanical Engineering, Quality Assurance, and Production to support milestone validation. You will contribute to troubleshooting and root cause analysis under supervision, ensuring all activities comply with cGMP and relevant industry standards.

You will have exposure to medical device regulations such as GAMP 5 and 21 CFR Part 11, with opportunities to develop test automation tools for improved workflow efficiency. This internship provides practical experience in a regulated pharmaceutical/medical device environment within a global company.

Requirements

Currently pursuing a Bachelor's degree in Electrical, Mechanical, Computer Engineering, Biotechnology, Pharmaceutical Science, or a 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 standard operating procedures (SOPs)
Excellent written and verbal communication skills
Preferably experience 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 including GAMP 5, 21 CFR Part 11, or ICH guidelines

Responsibilities

Assist in reviewing and drafting validation life cycle documents including URS, FS, and Testing Protocols (IQ/OQ/PQ)
Participate in validation execution on manufacturing equipment and software systems under supervision
Collect, analyze, and document test results to identify functional issues, performance bottlenecks, or deviations
Participate in troubleshooting issues discovered during validation and conduct root cause analysis (RCA)
Ensure all activities comply with internal procedures, cGMP, and other relevant industry standards (ISO, GAMP 5)
Work with cross-functional teams (ME, QA, Production) to support validation milestones
Contribute to developing test automation tools to improve workflow efficiency