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Principal Informatics Engineer
Eli Lilly and Company. Partner with Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams .
Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- Partner with Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams
- Implement and support digital laboratory solutions for the Foundry’s operational objectives
- Drive and support system design, configuration, validation, and release
- Serve as an IT subject matter expert for analytical laboratory IT systems
- Lead system 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 in compliance with 21 CFR Part 11 and EU Annex 11
- Lead data integrity requirements and ensure audit readiness
- Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms
- Support deployment and upgrades of analytical laboratory IT systems
- Produce and maintain CSV documentation, SOPs, and validation plans
- Ensure systems remain validated through releases, recapitalization, and retirement
- Ensure solution requirements comply with regulatory, legal, and quality requirements
- Collaborate with site and global IT teams to ensure operational readiness
- Organize and educate peers on system use and best practices
- Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation
Requirements
What you’ll need- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
- 5+ years of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area supporting informatics
- Experience with LIMS: LabVantage, LabWare
- Experience with ELN: Benchling, Signals Notebook, or equivalent
- Experience with Computer System Validation (CSV) methodology
- Strong working knowledge of analytical laboratory IT systems
- Experience with CDS: Empower, or equivalent
- Experience with LES/MES: L7, MODA, or equivalent
- Knowledge of CSV processes and electronic records/electronic signatures (ERES) requirements
- Experience working in a GMP-regulated environment
- Ability to prepare and implement IQ/OQ/PQ protocols and associated 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
- Certification in relevant IT areas, such as ITIL, cloud, or AI, is a plus
Benefits
Comp & perks- Company bonus, depending in part on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
- Flexible hybrid work model with three days onsite and two days working remotely each week