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.
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.
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Benefits
Vision insurance
Additional Information
Job Summary
Job Title: Intern, NPI & Validation - Malaysia
Department: Plant Engineering, NPI & Validation
Position Overview:
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.
Insulet · Gelang Patah, Johor