Informatics Engineer

• Partner with Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams
• Implement and support digital laboratory solutions for the Lilly Medicine Foundry
• Drive and support system design, configuration, validation, and release
• Lead design and configuration sessions for LIMS, LES, ELN, and CDS platforms
• Translate business and scientific processes into validated technical solutions
• Develop and implement IQ, OQ, and PQ protocols compliant with 21 CFR Part 11 and EU Annex 11
• Lead data integrity requirements and maintain audit readiness
• Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms
• Support deployment and upgrades of analytical laboratory IT systems
• Maintain CSV documentation, SOPs, and validation plans
• Ensure systems remain validated throughout releases, recapitalization, and retirement
• Ensure laboratory IT solutions comply with regulatory, legal, and quality requirements
• Collaborate with site and global IT teams on operational readiness
• Serve as IT subject matter expert for analytical laboratory IT systems
• Educate peers on system use and best practices
• Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and documentation

• Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
• 1+ year of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area
• Experience with Computer System Validation (CSV) methodology
• Authorized to work in the United States on a full-time basis
• No employer sponsorship or support for work authorization or visas
• Working knowledge of analytical laboratory IT systems, including LIMS, ELN, CDS, and LES/MES platforms
• Knowledge of CSV processes and electronic records/electronic signatures requirements
• Experience in a GMP-regulated environment
• Ability to prepare and implement IQ/OQ/PQ protocols and documentation
• Experience with API/middleware integration and instrument connectivity
• Understanding of data integrity frameworks applicable to GMP lab environments
• Familiarity with Agile or iterative delivery methodologies in a regulated setting
• Ability to translate business and scientific processes into IT requirements and solutions
• Effective communication across technical, quality assurance, and business audiences
• Certification in relevant IT areas such as ITIL, cloud, or AI is a plus

Demonstrates expertise in implementing and supporting digital laboratory solutions, ensuring compliance with regulatory requirements, and maintaining data integrity in GMP environments. Proficient in Computer System Validation (CSV) processes and capable of translating business and scientific needs into validated IT solutions.

• Computer System Validation (CSV)
• Laboratory Information Management Systems (LIMS)
• Analytical Laboratory IT Systems
• IQ/OQ/PQ Protocols
• GMP-Regulated Environment

• Computer System Validation
• LIMS
• LES
• ELN
• CDS
• API Integration
• Middleware Integration
• Data Integrity Frameworks
• Agile Methodologies
• Validation Documentation

• Effective Communication
• Collaboration

• ITIL Certification
• Cloud Certification
• AI Certification

• GMP
• 21 CFR Part 11
• EU Annex 11
• Quality Control
• Audit Readiness