Sr. Principal Associate - QC Analytical Equipment Support

About the role

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

This role ensures the reliability and performance of analytical laboratory equipment by overseeing maintenance, calibration, and troubleshooting activities across a range of instruments. It also supports equipment lifecycle management by coordinating installations, qualifications, and vendor interactions to maintain compliance and readiness for routine testing.

Responsibilities

• Manage routine and corrective maintenance, scheduled calibrations, and preventative maintenance on analytical laboratory instruments such as HPLC systems, spectrophotometers, balances, and incubators to ensure optimal working conditions.
• Monitor equipment performance, diagnose technical issues, execute first-line repairs, and serve as the on-site point person for vendor field service engineers and global support teams.
• Collaborate on the installation and qualification of new equipment through IQ/OQ/PQ activities, support change controls with technical input, and ensure instruments are properly requalified before release back to routine use.
• Execute all Quality Control activities in a timely manner, in compliance with applicable SOPs, methods/protocols, good documentation practices, data integrity standards (ALCOA+), cGMPs, EHS requirements, chemical hygiene, and biosafety guidelines, maintaining an ongoing state of inspection readiness and providing support during audits and inspections as requested.
• Identify and escalate atypical results and potential deviations, participate in root cause investigations and corrective/preventive actions, contribute to cross-functional teams and continuous improvement initiatives, and maintain training competencies to ensure only qualified work is performed.
• Lead QC analytical equipment onboarding for the new Richmond site, including defining instrument needs based on planned testing scope, selecting instruments from the AIQ marketplace, coordinating procurement and installation, and ensuring all equipment is fully qualified (IQ/OQ/PQ) and available for use prior to support site startup and routine testing.

Requirements

• Minimum of a bachelor's degree in a science, Engineering, or a related discipline.
• 7+ years of experience supporting analytical equipment within a GMP-regulated QC environment.

Skills/Preferences

• Prior experience performing preventive maintenance, calibration, and corrective maintenance on a broad range of QC analytical instruments (e.g., HPLC, GC, UV-Vis, balances, pH meters, dissolution apparatus) in a GMP-regulated laboratory.
• Demonstrated ability to troubleshoot instrument malfunctions, perform first-line repairs (e.g., lamp replacement, pump seal changes, flow cell cleaning), and effectively escalate complex issues to vendor field service engineers.
• Hands-on experience supporting equipment qualification activities (IQ/OQ/PQ), including coordination with validation teams, execution of qualification protocols, and post-repair requalification prior to returning instruments to routine use.
• Working knowledge of equipment lifecycle management practices, including change control authorship, equipment logbook documentation, calibration scheduling, and asset management within a CMMS or similar system.
• Experience acting as an on-site liaison with vendor service engineers during instrument repair, calibration, or qualification visits, ensuring all work is performed safely, documented properly, and compliant with site GMP requirements.
• Proficient in good documentation practices (GDP) and data integrity principles (ALCOA+).
• Proven ability to communicate and collaborate effectively with cross-functional teams.

Benefits

• 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
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Pay

The anticipated wage for this position is $101,250 - $169,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Schedule

May include on-call support. Position may include after-hours and company shutdown coverage. Short-term assignment at another Lilly facility outside of Richmond may be required for onboarding. Minimal travel (10% or less) is expected after onboarding.