LabVantage Deployment Specialist

Role Summary

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Responsibilities

• Site deployment: Lead the sites on the implementation of LabVantage through the different phases of deployment. Maintain deployment documentation, including site readiness checklists, issue logs, and lessons learned.
• LabVantage Domain Expert: Instruct on the to be processes in LabVantage (e.g. sample management, batch release, stability, lab execution). Act as a SME in one of the following areas: QA, QC Lab or Stability.
• Data Discovery Assistance: Assist sites during data discovery to identify the scope and the master data elements that need to be created as part of the LabVantage deployment.
• Change Management: Triage site change request, evaluate feasibility and global impact. Prioritize requests according to site needs.
• Key Process Indicators: Work with the project manager to identify and report key process indicators to report the progress of site deployments.
• Third-Party Management: Collaborate and manage third-party partners to successfully deploy LabVantage.
• Compliance: Work with the Global LabVantage team to ensure that the process designed in LabVantage are compliant with data integrity and GMP requirements.
• Global Process Standardization: Understand local requirements and apply them to standardized global business processes. Communicate new and changed business processes to sites and influence the sites to adopt these globally standardized processes and global tools to support the site’s intended use of LabVantage.
• Support Team Engagement and Issue Resolution: Provide ongoing support and issue resolution related to business processes in LabVantage. Involve Tech@Lilly for system related issues. Identify software gaps and/or business processes changes that must be created to support site deployment.
• Issues escalation: Raises issues to the Site Council and or LabVantage leadership team.
• Coach and mentor system users: share key learning and standard practices to increase their system knowledge, and identify transferable work processes between sites.
• Inspection Support: Provide answers to questions from inspections, audits, and other formal and informal assessments that impact globally owned applications and their Specialised workflows.
• System Release Support: Support system releases by implementing UAT and updating impacted procedures.
• Master Data Support: Act as an extended master data support when required by the master data workstream.

Qualifications

• Required: Bachelor’s degree
• Required: Minimum 3 years of laboratory experience
• Preferred: Bachelor’s degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field

Skills

• Experience working in/with GMP laboratories
• Strong scientific background
• Clear understanding of quality laboratory issues and activities
• Experience in defining and improving business processes
• Knowledge of cGMP and quality systems
• Solid understanding of GMP requirements and data integrity principles.
• Proven work with computer systems and their adaptability to existing business processes. Extensive knowledge of analytical methods, laboratory documentation and control processes.
• Knowledge of product release processes.
• Experience managing stability program.
• Ability to manage multiple priorities simultaneously.

Education

• Bachelor’s degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related field.

Additional Requirements

• This position will require occasional travel to manufacturing sites, development laboratories, and application vendors. Individuals must be willing to visit laboratory and manufacturing sites involving unique PPE and/or gowning requirements.
• This role is primarily on-site, with the flexibility to work from home four days a month.
• Location posted as Indianapolis but open to other locations where Lilly has a manufacturing site.