Principal Scientist – GMP Environmental Monitoring

Eli Lilly and Company

. Serve as technical owner and site SME for cleanroom environmental monitoring and utility monitoring programs .

Posted 10/21/2026full-timeLebanon • United StatesLead💰 $65,250 - $169,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in cleanroom environmental monitoring and utility monitoring programs, with a strong focus on compliance with cGMP, FDA, and ISO standards. Proficient in managing environmental monitoring data systems and leading investigations while ensuring safety and quality in manufacturing operations.

Highest-signal resume keywords

Environmental Monitoring ExpertiseGMP ComplianceMODA and LabVantage ProficiencyMicrobial Identification TechniquesAseptic Manufacturing Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Environmental MonitoringMicrobial Identification TechniquesEM Sampling InstrumentsQuality Management SystemsData AnalysisRisk AssessmentSOP AuthoringInstrument QualificationCalibration and MaintenanceCleanroom Qualification

Soft Skills

LeadershipTraining and MentoringCollaborationProblem-SolvingCommunication

Tools & Technologies

MODALabVantageTrackWiseVeeva VaultMetasysMet OneClimentAir IdealMAS 100PMS Systems

Industry Keywords

CGMPFDAEMAEU GMP Annex 1USPISO 1464421 CFR 210/211Bioburden TestingEndotoxin TestingAseptic Manufacturing

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Serve as technical owner and site SME for cleanroom environmental monitoring and utility monitoring programs
Shape sampling strategy, risk assessments, alert/action limits, and alignment with the contamination control strategy
Coordinate shift-based environmental monitoring activities in classified production areas
Support manufacturing operations and respond to production needs and environmental concerns
Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation activities
Review and approve environmental monitoring and laboratory records, SOPs, and controlled documents
Maintain accurate, audit-ready data in MODA and LabVantage
Own instrument qualification, calibration, maintenance, and method readiness
Lead root cause investigations for environmental excursions and manufacturing deviations
Partner with Manufacturing, Quality Assurance, Quality Control, and Facilities to close CAPAs on time
Maintain alignment with cGMP, FDA, EMA, EU GMP Annex 1, USP, ISO 14644, and 21 CFR 210/211
Present environmental monitoring data during regulatory inspections
Train, mentor, and develop environmental monitoring analysts and technicians
Plan staffing and resources, manage budget, and drive continuous improvement in efficiency and cost
Ensure laboratory, cleanroom, and manufacturing support work is performed safely and in GMP compliance

Requirements

What you’ll need

BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related life science field
5+ years of experience in GMP pharmaceutical microbiology or environmental monitoring, including experience interacting with regulatory agencies
Authorized to work in the United States on a full-time basis
Lilly will not provide support for or sponsor work authorization or visas
Experience with aseptic manufacturing or sterile drug product operations, such as fill-finish or lyophilization
Proficiency with EM data systems including MODA, LabVantage, and Metasys
Proficiency with quality management systems including TrackWise and Veeva Vault
Hands-on experience with EM sampling instruments including Met One, Climent, Air Ideal, MAS 100, gas sampling equipment, Lighthouse, and PMS systems
Working knowledge of microbial identification techniques including MALDI-TOF, Vitek, and Gram stain
Working knowledge of bioburden and endotoxin testing
Experience assisting with development of qualification curricula and on-the-job training plans
Experience in a greenfield or start-up GMP environment
Experience contributing to cleanroom qualification, SOP authoring from scratch, equipment selection and qualification, and establishing a quality culture
Ability to work in controlled cleanroom environments (ISO 5–8 / Grade A–D) and gown according to applicable SOPs
Ability to work occasional off-hours, weekends, or on-call shifts
Ability to stand for extended periods, walk throughout the facility, and perform gowning activities

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
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