Illumina is looking for a LIMS Process Engineer to launch and sustain our new Laboratory Information Management System (LIMS) at the Madison, WI site. Our team is responsible for guiding the activity that fuels Illumina's sequencing and array-based solutions for analysis of genetic variation and function in fields ranging from cancer research to agriculture.
In this role, you will manage configuration and change components of the LIMS architecture for Madison products from inception through end of life. Your tasks will involve 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.
Your workday will include coordinating with global and cross-functional teams in a dynamic, fast paced organization as you set and achieve your own milestones providing global networking opportunities and exposure to the Illumina portfolio.
- Support and iterate Laboratory Information Management System (LIMS) models and Electronic Lab Notebooks (ELN)
- Ensure the accuracy of system data through process evaluation and validation
- Understand master data and the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing and product release
- Manage Engineering Change Requests and Change Orders (ECRs/ECOs)
- Review and monitor implementation activities to ensure the change has been completed properly
Collaboration and Project Management Responsibilities:
- Engage Subject Matter Experts (SMEs) to ensure change and configuration documentation is accurate and complete, all relevant documentation is included, and appropriate implementation strategies and validation activities have been completed.
- Develop and maintain product and process configurations and collaborate on the implementation of solutions in LIMS, PLM and ERP
- Sustain, iterate, and improve LIMS for a QC laboratory area with respect to both configuration and core functionality while incorporating the voice of the customer.
- Identify, execute, and support process improvement initiatives of varying complexity engaging global, cross-functional support
- 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
- Direct experience creating and supporting modeling in LIMS/ELN (LabVantage or similar)
- Hands-on experience with common 3rd Party interfaces with LIMS/ELN applications like ERP, PLM, MES, SDMS, Instruments, etc.
- 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
- Demonstrated ability to convert process flows into automated workflow models
- Experience in configuration management, operations, and/or quality within a regulated industry.
- Solid understanding of computer system and software validations
Nice to Have:
- Working knowledge of ISO 13485 and cGMP requirements
- Technical background in QC, preferably in a life sciences, diagnostic, and/or medical device environment
- Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP
- Experience with Software Development Life Cycle of quality systems
- Product Lifecycle Management (PLM) experience
- Typically requires Bachelor's degree with 3-5 years of relevant experience
- OR related technical certification and experience
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. If you require accommodation to complete the application or interview process, please contact firstname.lastname@example.org. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf