Position Summary:
This position requires an individual who must work with minimal supervision to support the system configuration and modeling for the Illumina’s Laboratory Information Management System (LIMS). This person will join a dynamic, fast paced organization supporting new product development teams, as well as sustaining operations. This person is responsible for compiling relevant information related to product and process definition, analyzing business and compliance requirements, assessing risks for impact, and procuring accurate information for use in global systems. In addition to product configuration and change activities, tasks include support and iteration of LabVantage LIMS, management of Engineering Change Requests and Change Orders (ECRs/ECOs), workflow process development, and identification and participation in product and process improvements initiatives.
Responsibilities:
- Own, Support, and iterate system development life cycle for LIMS to develop and optimize manufacturing process flows
- Drive improved utilization of LabVantage for laboratory areas with respect to both configuration and core functionality, and act as “voice of the customer” for manufacturing
- Support Scientific Data Management System (SDMS) for instrument connectivity and seamless data integration
- Understanding of master data and the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing and product release
- Engage Subject Matter Experts (SMEs) to assure change and configuration documentation is accurate and complete, all relevant documentation is included, and appropriate implementation strategies and validation activities have been completed.
- Review and monitor implementation activities to ensure the change has been completed properly
- Responsible for the accuracy of system data through process evaluation and validation
- Develop and maintain product and process configurations and collaborate on the implementation of solutions in LIMS, PLM and ERP. Candidate must have a solid understanding of LIMS/PLM/ERP and changes to downstream cross functional areas and systems
- Identify, execute, and support process improvement initiatives of varying complexity engaging global, cross-functional support
- Able to work independently and requires minimal guidance to perform required tasks
- Work with peers and/or subordinates to ensure timely completion of projects and tasks
- Take initiative to develop and implement new processes to strengthen data accuracy or enhance efficiency
- Demonstrate effective communication style working with all levels of organizational structure, through multiple departments, and across global sites
- Provide leadership to junior level engineers and analysts
All listed responsibilities are deemed as essential functions to this position. However, business conditions may require reasonable accommodations for additional responsibilities.
Requirements:
- Direct hands-on experience managing configuration change management in LIMS, LabVantage LIMS preferred.
- Proven ability to convert process flows into automated workflow models
- Technical background in manufacturing, preferably in a life sciences, diagnostic, and/or medical device environment
- Familiarity with software programming languages, Java, Groovy preferred
- Experience in configuration management, operations, and/or quality within a regulated industry
- Hands-on experience with 3rd Party interfaces that are commonly interfaced with LIMS applications like ERP, PLM, MES, SDMS, Instruments, etc.
- Solid understanding of computer system and system validations
- Experience with Software Development Life Cycle of quality systems preferred
- Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP preferred
- Product Lifecycle Management (PLM) experience
- Working knowledge of ISO 13485 and cGMP requirements desired
- High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
