IT Systems Validation Coordinator - FDE

Job Description

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 35,000 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.

Position Brand Description:

Manufacturing and Quality Information and Digital Solutions (MQ IDS) supports manufacturing operational excellence and productivity efforts through utilization of information and technology. MQ IDS strives to enable the making of medicine “with safety first and quality always”. In the pharmaceutical manufacturing industry, a convergence of information technology (IT) and operations technology (OT) is occurring. The emergence of technologies related to “Industry 4.0” is transforming our operations. Significant investment and usage of data and analytics in the making of medicine is occurring where capabilities from simple visualizations to predictive and prescriptive analytics and machine learning are rapidly emerging across the global manufacturing landscape. The MQ IDS organization is engaged in an exciting phase of transformation as we drive our Digital Plant vision across Lilly manufacturing.

The Analyst –Indy API-Mfg (Validation Coordinator) provides technical leadership and guidance on Computer Systems Validation (CSV) for assigned projects. The individual acts as the key interface in understanding and communicating Computer System Validation policies and procedures between Validation Analysts (Technical Writers), Subject Matter Experts, Computer System Quality, and Project Managers. The Analyst –IAPI-Mfg (Validation Coordinator) will also promote a right-sized validation approach to ensure the appropriate level of validation is achieved.

Key Objectives/Deliverables:

• Provide strategic guidance on applying right-sized, risk-based approach to CSV
• Supply technical guidance on corporate and site CSV policies and procedures
• Ensure CSV deliverables are appropriately reviewed and meet all requirements of corporate and site CSV policies and procedures
• Implement processes to maintain CSV compliance
• Monitor integrity and accuracy of system inventory data
• Assist in ensuring any local policies and procedures are in alignment with corporate CSV policies and procedures
• Act as a contact for CSV issues during audits
• Escalate CSV issues immediately to appropriate people
• Apply/share standard CSV best practices across Lilly
• Partner with the customer to understand the business
• Openly seek out CSV approaches by other groups and incorporate best practices
• Initiate efforts to leverage already validated systems locally and from other sites

Basic Requirements:

• Bachelor’s Degree
• At least 2 years of experience in Computer System Quality (CSQ) and/or CSV policies and procedures

OR

• High School Diploma/GED with at least 5 years of experience in CSQ and/or CSV policies and procedures.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Preferences:

• FDA Part 11 and GAMP understanding preferred
• Good communication skills
• GMP knowledge and training
• Experience with validation of Quality Control Laboratory Systems, End User Systems, IT Systems, Process Analytics Systems, and Process Automation Systems in a GMP manufacturing environment preferred

Additional Information:

• This position is for a fixed duration of two years with the potential to extend for up to 4 years.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at [email protected].