Process Design & Control: Define and establish robust process parameters and Critical Process Parameters (CPPs) to ensure product quality and consistency.
Technology Transfer: Drive the successful transition of manufacturing processes from R&D/Development stages into full-scale commercial manufacturing.
Verification & PPQ: Oversee process verification activities during Engineering Runs and Process Performance Qualification (PPQ) phases.
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The Associate Engineer supports validation teams in ensuring new products, systems, or processes meet specified standards through documentation, testing, and data analysis under the guidance of senior staff. Key duties include preparing validation plans, documenting processes, performing tests, analyzing data, identifying issues, and maintaining compliance with regulatory standards. The (AE) must be proficient in strong analytical, communication, and technical writing skills, as well as attention to detail and the ability to work with cross-functional teams.
Develop and execute protocols to validate new and existing systems, processes, equipment, and software to ensure they consistently produce expected results.
Support Insulet Global and Malaysia Plant Engineering in all equipment and process validation activities includes but not limited to: FAT, SAT, IQ, TMV, OQ and PQ.
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Work with Senior NPI Engineer to Lead and support any New Product Introduction program that will be taken by Insulet.
Weekly Beat the Plan progress reports on project deliverables and timelines.
Manage Engineering Build Requests: Oversee the entire lifecycle of engineering build requests, from initial submission to final delivery, ensuring all requirements are met.
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Strategy Development: Formulate comprehensive CQV strategies and detailed execution plans tailored to specific manufacturing equipment and utility systems.
Phase Coordination: Lead and coordinate the execution of all project phases, including Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Readiness Verification: Rigorously verify equipment readiness and system integrity prior to handover to the production team.
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