At Lilly, the business and technical problem is to develop, deploy, and support Data Analytics capabilities at the Branchburg Manufacturing facility to meet business and regulatory needs, enhance decision-making, and support continuous improvement initiatives.
Requirements
- Basic understanding of databases (Oracle, SQL, etc.) and operating systems (Windows, etc.).
- 3+ years experience working with data analytics tools such as Power BI, Tableau, Spotfire or equivalent dashboarding tools.
- Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications.
- Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices.
- Including the use of AI technology for automation and/or simplification of work.
- Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.
- Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk, and follow quality management practices.
Responsibilities
- Create, modify, and enhance dashboards and systems to satisfy business information demands.
- Oversee and participate in the installation, configuration, and validation of key cGXP dashboards and tools.
- Manage system customizations, scripts, and user interface enhancements.
- Design and implement integrations between Systems and Data Lake / Data Hub /Data Repositories to leverage when creating dashboarding capabilties.
- Perform the pre-validation assessment of all cGXPsystems and dashboards, ensuring that all validation requirements have been met prior to system testing.
- Enable data-driven decision making in pharmaceutical Quality Control and Manufacturing by developing and deploying interactive, easy-to-use dashboards and reports that support self-service analytics, ensure secure and compliant access to critical data, and provide real-time insights to enhance process efficiency, product quality, and regulatory compliance.
- Identify, recommend, and implement automated solutions to address QC laboratory or manufacturing operations.
Other
- Assure adherence of applicable regulatory (i.e. cGXP, CFR, etc.) practices during execution of all work activities.
- Participate in audits, inspections, and associated readiness activities.
- Proven ability to translate user requirements into dashboards and tools that drive business value.
- Responsible for daily support of end users, and provide end user training for all dashboards and analytics created.
- Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with the customers and other members of the IDS organization.
