Apply

Ready to go for it?

AI Apply speeds things up—apply directly if you prefer.

FREE ACCESS
5,000–10,000 jobs/day
Scoutfield Logo

See all jobs on Scoutfield

Search thousands of fresh jobs every day.

Discover
  • Fresh listings
  • Fast filters
  • No subscription required
Create a free account and start exploring right away.
Eli Lilly and Company

Principal Scientist, GMP Microbiology – Critical Utilities Qualification & Monitoring

Eli Lilly and Company

. Develop sampling plans, point-of-use maps, and risk-based alert/action levels for the utility monitoring program .

Posted 10/6/2026full-timeCarmel • United StatesLead💰 $66,000 - $171,600 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GMP microbiology and utility monitoring, with a strong focus on sampling, testing, and compliance with regulatory standards. Proficient in LIMS configuration and quality systems, with hands-on experience in cleanroom environments and utility systems.

Highest-signal resume keywords
GMP MicrobiologyUtility MonitoringLIMS ProficiencyMicrobial IdentificationCleanroom Experience

ATS Keywords

Tailor your resume
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Sampling PlansRisk-Based Alert LevelsWater and Gas System QualificationBioburden TestingEndotoxin TestingTOC TestingConductivity TestingMicrobial IdentificationCAPA InvestigationsGMP Compliance
Soft Skills
Training PersonnelCollaborationProblem-Solving
Tools & Technologies
LIMSLabVantageMODAVeeva VaultMALDI-TOFVitek
Industry Keywords
CGMPFDAEU GMP Annex 1USP RequirementsCleanroom StandardsBiologics OperationsGenetic Medicine Operations

Tech Stack

Tools & technologies
Vault

About the role

Key responsibilities & impact
  • Develop sampling plans, point-of-use maps, and risk-based alert/action levels for the utility monitoring program
  • Author, execute, and summarize protocols and reports for phased water and gas system qualification
  • Oversee utility sampling and testing for bioburden, endotoxin, TOC, conductivity, microbial identification, particulates, steam quality, and gas testing
  • Trend results, identify adverse trends, and prepare periodic trend and system review reports
  • Support LIMS (MODA) configuration and review records, SOPs, and controlled documents
  • Support deviation, OOS/OOT, excursion, CAPA, and change control activities with Utilities, PT&E, and Quality
  • Maintain alignment with cGMP, FDA, EU GMP Annex 1, and USP requirements and present utility data during audits and inspections
  • Train sampling personnel and coordinate contract laboratory partners
  • Partner with Utilities, PT&E, Manufacturing, and Quality
  • Serve as an escalation point for utility excursions and support root cause investigations
  • Travel less than 10% domestically
  • Work in cleanroom and utility areas at the initial Parkwood West location, with permanent placement at the Lilly Medicine Foundry

Requirements

What you’ll need
  • BS or MS in Microbiology, Biology, Chemistry, or a related life science discipline
  • 3+ years of experience in GMP microbiology or utility monitoring, including water and/or process gas sampling and investigations/CAPA
  • Authorized to work in the United States on a full-time basis
  • Greenfield or start-up GMP facility experience, including commissioning and qualification
  • Hands-on experience with WFI/PW, clean steam, compressed air, and nitrogen/process gas systems
  • Proficiency with LIMS/trending tools, including LabVantage and MODA
  • Experience with quality systems, including Veeva Vault
  • Knowledge of microbial identification using MALDI-TOF and Vitek
  • Knowledge of sterile, biologics, or genetic medicine operations
  • Ability to work regularly in cleanroom and utility areas (ISO 5–8 / Grade A–D), with gowning per SOP
  • May require occasional off-hours or weekend support during startup and qualification
  • Physical ability to stand for extended periods, walk throughout the facility, and gown

Benefits

Comp & perks
  • Company bonus depending partly on company and individual performance
  • Company-sponsored 401(k)
  • Pension
  • Vacation benefits
  • Medical, dental, vision, and prescription drug benefits
  • 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