- Supervise and assist in computer systems validation activities, ensuring documentation compliance for non-GMP and GMP systems
- Lead risk management strategies for CSV at Lilly's Lebanon facilities
- Act as the primary contact for internal and external CSV audits, working closely with Quality Assurance
- Ensure Data Integrity readiness for regulatory inspections and represent the company during audits
- Collaborate with internal and external partners to maintain compliance of computer systems
- Participate in business planning and governance activities
- Contribute to GMP designation and testing requirements for analytical tools
- Ensure all IT systems meet security and privacy standards
- Bachelor's Degree in Information Systems, Computer Science, Engineering, or related field
- Experience in regulated industries and quality processes in IT
- Strong communication skills and ability to interact with various stakeholders
- Demonstrated integrity, leadership, and initiative
- Proficiency in compliance, privacy, and SDLC processes
- Knowledge of cGMPs, production practices, and quality systems
- Understanding of CSV and data integrity regulations
- Ability to think creatively, adapt to changes, and propose new ideas
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Lab IT Analyst
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Warehouse Systems Analyst
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Financial Analyst
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Data Analyst
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HRIS Analyst
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First Commonwealth Bank Indiana, United States Full timeAs an HRIS Analyst at First Commonwealth, your primary focus is providing HR system support across the organization, reporting and ensuring the integrity of the HR data within the UKGPro system. The HRIS Analyst creates and maintains complex Cognos Business Intelligence (BI) repo ...
IT Analyst - Lebanon, United States - BioSpace, Inc.
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Description
New Career OpportunityAre you interested in joining a global healthcare leader dedicated to improving lives around the world? At our Indianapolis headquarters, Lilly is at the forefront of discovering and delivering life-changing medicines, advancing disease management, and giving back to communities through philanthropy. If you are passionate about making a difference, we have an exciting opportunity for you!
About the Company:
Lilly is currently establishing an innovative facility in Lebanon, Indiana, focusing on manufacturing new modalities like Gene Therapy. This state-of-the-art site will utilize cutting-edge technologies and advanced data analysis to ensure safety, quality, and process efficiency. Joining the team at this greenfield site means being part of a unique startup experience, where you will contribute to designing, commissioning, and launching the facility for both clinical and commercial purposes.
Position Overview:
Eli Lilly and Company is dedicated to fostering a diverse and inclusive workforce, providing equal opportunities for all individuals. Join us at Lilly and be part of a supportive network that nurtures talent and encourages growth. Check out our various employee resource groups and discover the power of diversity and inclusion at Lilly.