3.0 - 7.0 years

0 Lacs

karnataka

On-site

The work you do every day at Illumina has the potential to impact the lives of people you know, as well as humanity as a whole. Illumina is dedicated to expanding access to genomic technology to achieve health equity for billions of individuals worldwide. This commitment leads to groundbreaking discoveries that revolutionize human health by enabling early disease detection, diagnosis, and innovative treatment options for patients. Being a part of Illumina means contributing to a larger purpose. Regardless of your role, you have the chance to make a meaningful difference. Surrounded by exceptional individuals, visionary leaders, and groundbreaking projects, you will exceed your expectations and discover your full potential. We are currently looking for a PLM Analyst to join our skilled team in Bangalore. In this role, you will play a crucial part in managing the core operations related to the Product Lifecycle within a dynamic and fast-paced organization, focusing on both new product development and on-market commercial operations. Your responsibilities will include creating and submitting change control requests, serving as a key resource in the change management process from initiation to product end-of-life for Illumina products, and maintaining product and process configurations in PLM and SAP ERP. You will collaborate with cross-functional teams to create Change Requests and Change Orders, ensuring that configuration and document changes contain all necessary information and addressing any arising issues. Responsibilities: - Utilize problem-solving skills to analyze the scope of Change and the relevant business dataset (e.g., Items, Documents, Bill of Materials, Facilities, EH&S). - Package Change scope efficiently into Change Requests and Change Orders to enhance operational efficiencies. - Prioritize processing Changes while aligning with defined Service Levels and expected metrics (e.g., turnaround time and quality service level). - Conduct comprehensive data analysis based on the Change scope to achieve a higher accuracy level of impacted items, including Item and Document searches by key attributes and descriptions within PLM and related systems (e.g., SAP, Camstar, LIMS). - Verify the accuracy and completeness of Change packages by collaborating with other Change Originators when necessary, following established procedures, work instructions, or job aids. - Perform data quality reviews during Change workflows, assessing data integrity risks, ensuring data completeness and accuracy, and advancing PLM workflows through lifecycle stages. Experience Required: - 3-5 years of prior professional experience in the PLM space of a MedTech company with a solid understanding of Enterprise Change Management, Master Data Management, and Enterprise Document Control. - Familiarity with basic GMP, regulatory, and compliance requirements of a MedTech company, such as 21 CFR 820 (Quality System Regulation), 21 CFR Part 11 (Electronic Records and Electronic Signatures), and 21 CFR Part 809 (In-Vitro Diagnostic Products). - Previous experience in a Data Stewards role handling Item and Document Master Data within a controlled environment is preferred.,

Posted 6 days ago

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