Sr. Principal Associate - QC Analytical Equipment Support

Regulatory Jobs; Richmond (VA); On-site; USD 101,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Well-being/health programs

Job summary

Lilly is seeking an experienced analytical equipment specialist to ensure reliability across laboratory instruments at our Richmond site. The role emphasizes maintenance, calibration, troubleshooting, and collaboration with vendors to keep QC operations compliant and efficient.

The successful candidate will lead installation and qualification activities (IQ/OQ/PQ), support root-cause investigations, and help drive continuous improvement for analytical systems in a GMP environment.

Qualifications

• Bachelor's degree required in science, engineering, or related field.
• 7+ years of experience in supporting analytical equipment in GMP QC environments.
• Authorized to work in the United States full-time.

Responsibilities

• Perform routine and corrective maintenance on analytical instruments (HPLC, spectrophotometers, balances, incubators).
• Coordinate installations, qualifications (IQ/OQ/PQ), and vendor interactions.
• Support calibration schedules and instrument requalification prior to reuse.

Skills

Maintenance expertise

Calibration

GMP compliance

Troubleshooting

Vendor liaison

Data integrity

Education

Bachelor's degree in Science/Engineering

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

Position Overview:

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.

This position is a recognized expert who makes key technical decisions impacting multiple teams, leads the resolution of highly complex challenges, and influences technical strategy across functions. The role delivers innovations with cross-functional impact, leads significant initiatives, mentors outside their own discipline, and serves as an effective supporter of culture change.

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 elevate 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.

Basic 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.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional 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, icIEF, capillary electrophoresis, PCR) in a GMP-regulated laboratory.
• Breadth and experience across technologies leveraged in a large molecule GMP laboratory.
• Demonstrated ability to troubleshoot instrument malfunctions, perform first-line repairs (e.g., lamp replacement, pump seal changes, flow cell cleaning), and effectively upscale 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+).
• Collaborated in document drafting and execution of GMP instrument/software qualifications with solid quality and delivery
• Proven ability to communicate and collaborate effectively with cross-functional teams.
• Implemented data integrity solutions to align with Part 11 and PICS requirements and trends.

Additional Information

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. 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). 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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