Lilly is looking to solve the problem of optimizing manufacturing processes and increasing capacity for clinical trial medicines while reducing costs and environmental impact through the creation of the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development.
Requirements
- Minimum B.S. in IT, Engineering or related discipline and 3+ years’ experience in Computerized System Validation and Data Analytics, preferably in pharmaceutical manufacturing
- Knowledge of GMP regulatory requirements, computer system validation, execution and data integrity
- Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, Power BI, QMS and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, Veeva, Analysis tools, Aveva PI)
- Experience with data flows and interfaces associated with instrumentation and system integration protocols
- Working experience administering relational databases with RDBMS tools such as Microsoft SQL Server Management Studio
- Basic to intermediate competency with SQL, PowerBI and software development applications
- Experience with design and development of data analysis and data contextualization to support site functions and metrics
Responsibilities
- Provide/Support input to design decisions regarding development and integration of Automation Data Analytics systems and overall Foundry Data Analytics initiatives
- Lead development and implementation of analytics strategies and tools for metrics, visualization and dashboards based on complex user requirements across multiple platforms and functional areas
- Interface with the Automation teams and the user groups to develop requirements and designs to meet the business needs
- Support qualification and delivery of Automation Servers, Network and Infrastructure and applications
- Support the Process Control Validation Plan, CSV, Quality Documents, SOP’s and Audit Readiness
- Act as a system owner for the electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems
- Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity) and corporate Lilly quality policies and procedures
Other
- Minimum B.S. in IT, Engineering or related discipline
- 3+ years’ experience in Computerized System Validation and Data Analytics, preferably in pharmaceutical manufacturing
- Ability to work in a matrix organization within the department and cross functionally and demonstrate key interpersonal skills
- Ability to ensure appropriate technical depth and rigor with departmental technical deliverables
- Ability to make decisions independently and to network with others as appropriate
- Ability to work with key network and enterprise partners in utilizing new technology in data analytics and enterprise integration
