At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization Overview:
Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
The Computer Systems Quality Assurance role is responsible for oversite of computer system validation at the Eli Lilly Lebanon API Manufacturing facility. This role includes working with Automation, QC labs, and Tech@Lilly persons to develop validation strategies for the approach to computer system validation in compliance with corporate standards; consultation and interpretation on applying and right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in internal and external Regulatory agency inspections; conducting evaluations of internal or supplier quality practices; maintenance of inspectional readiness; and external benchmarking of computer system validation practices.
Responsibilities:
Deliver on CS processes:
Establish and maintain CSQ support and sustainability processes.
Deliver Projects and Programs
Understand customer, company, and Quality priorities, and support implementation goals.
Provide linkages to partner organizations with CSV including Automation/Engineering, Site Equipment Verification, Business QA, and other CSQA persons.
Grow Capabilities and Knowledge
Mentor others in CSQA / CSV-related roles
Maintain Inspection Readiness
Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility.
Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems.
Monitor current state of inspection-readiness.
Escalate issues appropriately.
Streamline and Continuously Improve
Promote common process and best practice across functions.
Identify systemic issues and trends across functions and drive improvement activity.
Understand the external environment/best practices and bring external learning back to Lilly.
Basic Requirements:
Bachelor’s degree in computer science, Engineering, Life Sciences, or a technology-related field OR 10+ years of relevant experience
3+ years of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry
Additional Preferences:
Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+).
Direct experience with computer system validation of automation systems such as DeltaV and PLC's.
Previous experience in GMP production environments
Demonstrated strong oral and written communication skills.
Strong interpersonal interaction skills
Proven ability to influence quality peers, IT SMEs, and upper management.
Previous experience in Business Quality Assurance and Automation
Additional Information:
This is an on-site position in Lebanon, IN
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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400Full-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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