Job Description
What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
PLM Senior Analyst will be an integral part of running core operations for the Product Lifecycle of a dynamic, fast paced organization for both new product development and on market commercial operations. The person in this role is responsible for creating and submitting change control and managing them through closure, while serving as a critical resource in the change management process from inception through end-of-life for Illumina products. Maintains product and process configurations in PLM and SAP ERP. Supports cross-functional teams on the creation and management of Change Requests and Change Orders and assures configuration and document changes include required information while resolving any issues that arise.
Scope of Responsibility:
- Analyzes and evaluates Change scope to determine feasibility and impacted Products, Projects
- Applies problem-solving skills to analyze scope of Change and the underlying business dataset (e.g., Items, Documents, Bill of Materials, Facilities, Instruments/Equipments, EH&S)
- Packages Change scope in the form of Change Request and Change Orders – in the most efficient manner, in order to bring efficiencies to scale
- Links Changes to critical dataset e.g., Specifications, Projects, Products and other relevant Changes e.g., Parent Changes
- Prioritizes processing Changes in full alignment with the defined Service Level and expected metrics (e.g., turnaround time and quality service level)
- Performs thorough data analysis in light of the Change scope, in order to achieve higher accuracy level of impacted items. Scope includes, but not limited to Item and Document search – by key attributes, and descriptions both within PLM and PLM ecosystem e.g., SAP, Camstar, LIMS etc.
- Verifies accuracy and completeness of Changes packages by other Change Originators – where necessary, in full conformance with the underlying procedures, work instructions or job aids.
- Builds implementation plan – as per the outcome of Change Request Assessment
- Performs Document Redlines – in full conformance with Good Documentation Practice (GDP) principles and Change scope. Set effectivity dates once the Change is approved.
- Performs data quality review while processing Change workflows. Review risk towards data integrity, check for data completeness and accuracy while advancing PLM workflows through lifecycle stages
Experience Required:
- 2-6 years of prior professional experience in the PLM space of a MedTech company with working knowledge of Enterprise Change Management, Master Data Management and Enterprise Document Control
- Well versed with basic GMP, GDP, regulatory and compliance requirements of a MedTech company e.g., 21 CFR 820 (Quality System Regulation), 21 CFR Part 11 (Electronic Records and Electronic Signatures) and 21 CFR Part 809 (In-Vitro Diagnostic Products)
- Prior experience of Data Stewards role processing Item and Document Master Data in a controlled setup is preferred
- Prior experience of Document Control or Document Data Steward for a Life Science company is preferred
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
