Intern, NPI & Validation Engineering

Responsibilities

• Assist in reviewing and drafting validation lifecycle documents, including URS, FS, and IQ/OQ/PQ protocols and reports
• Participate in validation execution on manufacturing equipment and software systems under supervision
• Collect, analyze, and document test results to identify functional issues or performance deviations
• Support troubleshooting efforts and participate in root cause analysis (RCA)
• Ensure all activities comply with internal procedures, cGMP, and relevant industry standards like ISO or GAMP 5
• Collaborate with cross-functional teams including Manufacturing Engineering, Quality Assurance, and Production
• Contribute to the development of test automation tools to improve workflow efficiency

Requirements

• Currently pursuing a Bachelor’s degree in Electrical, Mechanical, or Computer Engineering, Biotechnology, Pharmaceutical Science, or a related field
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
• Basic understanding of validation methodologies and medical device quality principles
• Strong attention to detail and ability to follow strict standard operating procedures (SOPs)
• Excellent written and verbal communication skills

Preferred Qualifications

• Experience with scripting languages such as Python or SQL for data validation
• Familiarity with lab equipment such as oscilloscopes or multimeters
• Knowledge of medical device regulations including GAMP 5, 21 CFR Part 11, or ICH guidelines

About the Company

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Omnipod Insulin Management System provides a unique, wearable, and tubeless alternative to traditional insulin delivery methods.