Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry

Lilly • Indianapolis, IN

22h • $66,000 - $171,600 • Onsite

About The Position

The Principal Scientist, GMP Environmental Monitoring (EM) serves as the technical owner for cleanroom environmental monitoring and utility monitoring programs supporting GMP manufacturing at the Lilly Medicine Foundry Analytical GMP Laboratory. The role oversees daily EM team operations, ensures compliant and timely monitoring in classified manufacturing areas, and supports contamination control and production readiness. The Principal Scientist provides technical guidance, develops EM technicians and analysts, and serves as the primary escalation point for cleanroom and environmental excursions.

The position partners with Manufacturing, QC, Facilities, and Quality Assurance to maintain inspection readiness; leads and supports root cause investigations; and ensures compliance with cGMP, ALCOA+, and applicable quality and regulatory requirements. It also shapes sampling strategies, risk assessments, alert/action limits, and the contamination control strategy; supports facility and utility qualification and validation; reviews and approves records and controlled documents; and ensures monitoring equipment and methods remain qualified and ready.

The initial work location is Parkwood West in Carmel, Indiana, with occasional work at Lilly Technology Center in Indianapolis. The permanent location will be the Lilly Medicine Foundry in Lebanon, Indiana. The role involves regular work in controlled cleanroom environments (ISO 5–8 / Grade A–D), with gowning required under applicable SOPs. Domestic travel is less than 5%. Occasional off-hours, weekend, or on-call availability may be needed for critical manufacturing campaigns or investigation response.

Requirements

• BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related life science field.
• At least 5 years of experience in GMP pharmaceutical microbiology or environmental monitoring.
• Experience interacting with regulatory agencies.
• Authorization to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

• Experience with aseptic manufacturing or sterile drug product operations, such as fill–finish or lyophilization.
• Proficiency with environmental monitoring data systems, including MODA, LabVantage, and Metasys, and quality management systems such as 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, and 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, including cleanroom qualification, authoring SOPs from scratch, equipment selection and qualification, and establishing a quality culture.

Responsibilities

• Own the technical direction of cleanroom and utility monitoring programs, including sampling strategies, risk assessments, alert/action limits, and alignment with the contamination control strategy.
• Coordinate shift-based environmental monitoring activities in classified production areas and support manufacturing operations and real-time production needs.
• Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation activities.
• Review and approve environmental monitoring and laboratory records, SOPs, and controlled documents, ensuring data integrity and audit readiness.
• Manage instrument qualification, calibration, maintenance, and method readiness.
• Lead root cause investigations for environmental excursions and manufacturing deviations, and partner with relevant teams to close CAPAs on time.
• Maintain inspection readiness and present environmental monitoring data during regulatory inspections.
• Train, mentor, and develop EM analysts and technicians, reinforcing aseptic practices and a Right First Time quality culture.
• Plan staffing and resources to meet production schedules, manage budget, and improve efficiency and cost.
• Ensure laboratory, cleanroom, and manufacturing support work is performed safely and in compliance with GMP requirements.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal