Lilly
Healthcare
ManagerBusinessSolutions-LabITSystemsLead
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager Business Solutions - Lab IT Systems Lead at Lilly. Skills: CSV, Data Integrity, Lab IT Systems. Ensure manufacturing Labs systems deployed with validation documents. Ensure computerized labs instruments deployed with validation documents”
Industry & Context.
Analytical; Problem-solving; Root cause analysis; Troubleshooting
Occasional extended hour, Off-hour work, Travel as required
What They're Looking For.
Must Have
Data Integrity (DI) knowledge, Proficiency with CSV, Solid knowledge of Computer System Validation, Solid knowledge of Data Integrity, Excellent communication and interpersonal skills, Analytical and problem-solving skills, Ability to effectively prioritize and escalate issues, Adaptability
Nice to Have
Previous Agile experience, Experience deploying new system implementations, Experience in standing up greenfield facilities
What You'll Do.
Ensure manufacturing Labs systems deployed with validation documents
Ensure computerized labs instruments deployed with validation documents
Monitor Laboratory IT Systems
Monitor Laboratory Instruments
Execute Laboratory IT Systems
Execute Laboratory Instruments
Maintain Laboratory IT Systems
Maintain Laboratory Instruments
Lead validation of laboratory equipment
Lead validation of software systems
Support validation of laboratory equipment
Support validation of software systems
Support establishment of validated state
Support maintenance of validated state
Perform periodic review cycles
Partner cross-functionally with site DI SMEs
Ensure common systematic approach
Support site deployment of laboratory IT systems
Support upgrade of laboratory IT systems
Establish relationships with Global Quality Laboratory Network
Establish relationships with Global IT team members
Establish relationships with Site IT team members
Establish relationships with Computer System Quality Assurance
Establish relationships with site Quality Assurance
Establish relationships with external vendor/supplier organizations
Provide oversight of systems
Provide oversight of instruments
Support continuous improvement of systems
Support continuous improvement of instruments
Apply knowledge of quality principles
Apply knowledge of cGMP
Apply knowledge of laboratory systems
Develop local procedures
Develop training courses
Manage internal audit activities
Manage inspection activities
Support internal audit activities
Support inspection activities
Perform change control
Perform investigations
Perform root cause analysis
Perform activity planning
Perform System Administration for E3B system
Coordinate technical evaluation of new systems
Coordinate technical evaluation of existing systems
Provide CSV consulting
Assist with articulation of CSV needs
Lead DI/CSV related deviations
Lead DI/CSV related CAPAs
Participate in DI/CSV related deviations
Participate in DI/CSV related CAPAs
Ensure Lilly information assets protected
Restrict access to information
Lead team of contract resources
Manage labs instruments
Support labs instruments
How You'll Work.
Team & Collaboration
Cross-functional teams; Global Quality Laboratory Network; Global and Site IT team members; Computer System Quality Assurance; Site Quality Assurance; External vendor/supplier organizations
Communication Scope
Articulate complex technical concepts
Process & Methodology
Agile, CAPA
Full Job Description
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. **Position Brand Description:** Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 Billion to create a new state-of-the-art manufacturing site for Drug Substance, in Lebanon, Indiana. The brand-new facility will utilize a variety of Platforms and have the latest technology for API Manufacturing and Technology. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Lebanon API Manufacturing site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss! **What You’ll Be Doing** : You will be part of Technology at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Technology at Lilly MQ strives to enable the making of medicine “with safety first and quality always”. As a Lab CSV and Compliance Analyst, you will ensure the manufacturing Labs systems (MODA, LabVantage, NuGenesis, Empower, WInKQCL, etc) as well as computerized labs instruments are deployed with proper and right sized validation documents at LP1. Once systems and Instruments are deployed, this role will evolve into monitoring, execution, and m
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