Laboratory IT System Engineer - Lilly Medicine Foundry
Role details
Job location
Tech stack
Job description
As a Laboratory IT Systems Engineer, you will partner with the Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions that enable the Foundry's operational objectives. Your scope includes key lab systems such as Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Environmental Monitoring (EM) platforms.
You will be responsible for driving and supporting system design, configuration, validation, and release - serving as an IT subject matter expert (SME) for analytical laboratory IT systems at the Foundry.
How You'll Succeed:
System Implementation & Configuration
- Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS platforms, translating business and scientific processes into validated technical solutions.
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11.
- Manage data integrity requirements across lab systems and ensure audit readiness for regulatory inspections.
- Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms.
- Support site deployment and upgrade of analytical laboratory IT systems throughout the facility's startup and operational phases.
Validation & Compliance
- Produce and maintain Computer System Validation (CSV) documentation, standard operating procedures (SOPs), and validation plans in alignment with applicable regulatory frameworks.
- Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement.
- Build and maintain awareness of regulatory, legal, and quality requirements impacting the quality control laboratory, ensuring solution requirements comply.
Stakeholder Collaboration & Readiness
- Collaborate with site and global IT system teams to ensure operational readiness of laboratory systems supporting the Foundry's go-live objectives.
- Act as a key IT SME for analytical laboratory IT systems, organizing and educating peers on system use and best practices.
- Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.
Requirements
- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.
- 3+ years of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area.
- Demonstrated experience with Computer System Validation (CSV) methodology.
Additional Skills / Preferences:
- Strong working knowledge of analytical laboratory IT systems including:
- LIMS: LabVantage, LabWare, or equivalent
- ELN: Benchling, Signals Notebook, or equivalent
- CDS: Empower, or equivalent
- LES/MES: L7, MODA, or equivalent
- Solid knowledge of CSV process and electronic records/electronic signatures (ERES) requirements.
- Experience working in a GMP-regulated environment (pharmaceutical, biotech, or equivalent).
- Demonstrated ability to prepare and execute IQ/OQ/PQ protocols and associated documentation.
- Experience with API/middleware integration and instrument connectivity between lab equipment and informatics platforms.
- Understanding of data integrity frameworks applicable to GMP lab environments.
- Familiarity with Agile or iterative delivery methodologies in a regulated setting.
- Demonstrated learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues through sound problem-solving.
- Ability to accurately translate business and scientific processes into IT requirements and solutions.
- Effective communicator across diverse forums and audiences, including technical peers, QA, and business stakeholders.
- Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.
Benefits & conditions
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $184,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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